Device‐modified trabeculectomy for glaucoma

Xue Wang; Rabeea Khan; Anne Coleman

doi:10.1002/14651858.CD010472.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Forest plot of comparison: 2 Trabeculectomy + Ex‐PRESS versus Trabeculectomy, outcome: Postoperative IOP at one year.

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Figure 4

Forest plot of comparison: 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), outcome: 2.1 IOP at one year.

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Figure 5

Forest plot of comparison: 4 Trabeculectomy + AMT (amniotic membrane) versus Trabeculectomy, outcome: 4.1 Postoperative IOP at one year.

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Figure 6

Forest plot of comparison: 1 Trabeculectomy + E‐PTFE versus Trabeculectomy, outcome: 1.1 Postoperative IOP at one year.

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Analysis 1.1

Comparison 1 Trabeculectomy (Trab) + Ex‐PRESS versus Trabeculectomy (Trab), Outcome 1 Postoperative IOP at one year.

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Analysis 1.2

Comparison 1 Trabeculectomy (Trab) + Ex‐PRESS versus Trabeculectomy (Trab), Outcome 2 Postoperative IOP at six months.

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Analysis 1.3

Comparison 1 Trabeculectomy (Trab) + Ex‐PRESS versus Trabeculectomy (Trab), Outcome 3 Postoperative IOP at two years.

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Analysis 1.4

Comparison 1 Trabeculectomy (Trab) + Ex‐PRESS versus Trabeculectomy (Trab), Outcome 4 Postoperative logMAR BCVA at one year.

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Analysis 1.5

Comparison 1 Trabeculectomy (Trab) + Ex‐PRESS versus Trabeculectomy (Trab), Outcome 5 Complications.

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Analysis 2.1

Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 1 IOP at one year.

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Analysis 2.2

Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 2 Postoperative IOP at day one.

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Analysis 2.3

Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 3 Postoperative IOP at six months.

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Analysis 2.4

Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 4 Postoperative IOP at two years.

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Analysis 2.5

Comparison 2 Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab), Outcome 5 Complications.

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Analysis 3.1

Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 1 Postoperative IOP at one year.

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Analysis 3.2

Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 2 Postoperative IOP at one day.

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Analysis 3.3

Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 3 Postoperative IOP at one week.

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Analysis 3.4

Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 4 Postoperative IOP at one month.

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Analysis 3.5

Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 5 Postoperative IOP at three months.

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Analysis 3.6

Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 6 Postoperative IOP at six months.

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Analysis 3.7

Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 7 Postoperative IOP at two years.

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Analysis 3.8

Comparison 3 Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab), Outcome 8 Complications.

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Analysis 4.1

Comparison 4 Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab), Outcome 1 Postoperative IOP at one year.

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Analysis 4.2

Comparison 4 Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab), Outcome 2 Hypotony at 24 months.

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Analysis 4.3

Comparison 4 Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab), Outcome 3 Hyphaema at 24 months.

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Analysis 4.4

Comparison 4 Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab), Outcome 4 Inflammation at 24 months.

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Analysis 4.5

Comparison 4 Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab), Outcome 5 Shallow anterior chamber at 24 months.

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Analysis 4.6

Comparison 4 Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab), Outcome 6 Flat anterior chamber at 24 months.

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Analysis 4.7

Comparison 4 Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab), Outcome 7 Choroidal detachment at 24 months.

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Summary of findings for the main comparison. Summary of findings for Ex‐PRESS

Ex‐PRESS implanted during trabeculectomy compared with trabeculectomy alone for people with open‐angle glaucoma
Patient or population: people with open‐angle glaucoma Settings: ophthalmic surgery Intervention: Ex‐PRESS implanted during trabeculectomy Comparison: trabeculectomy alone
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Eyes (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	trabeculectomy alone	Ex‐PRESS
Postoperative mean IOP at 1 year	The mean IOP in the trabeculectomy‐alone groups was 13.9 mm Hg, ranged from 11.6 to 16.4 mm Hg	The mean IOP in the Ex‐PRESS groups was 1.58 lower (2.74 lower to 0.42 lower)	‐	165 (3 studies)	⊕⊕⊝⊝ low^1,2	‐
Postoperative mean logMAR BCVA at 1 year	The mean logMAR BCVA in the trabeculectomy‐alone groups was 0.59, ranged from 0.43 to 0.80	The mean logMAR BCVA in the Ex‐PRESS groups was 0.15 lower (0.40 lower to 0.10 higher)	‐	90 (2 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Complication as defined in protocol‐ Hypotony Follow‐up: ranged from 1 to 5 years	565 per 1000	520 per 1000 (356 to 751)	RR 0.92 (0.63 to 1.33)	94 (2 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Other complications reported by included studies
Shallow/flat anterior chamber Follow‐up: ranged from 1 to 5 years	150 per 1000	108 per 1000 (60 to 198)	RR 0.72 (0.40 to 1.32)	294 (4 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Bleb leakage Follow‐up: ranged from 1 to 5 years	48 per 1000	60 per 1000 (24 to 154)	RR 1.26 (0.50 to 3.20)	294 (4 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Hyphema Follow‐up: ranged from 1 to 5 years	82 per 1000	27 per 1000 (10 to 77)	RR 0.33 (0.12 to 0.94)	294 (4 studies)	⊕⊕⊝⊝ low^1,2	‐
Cataract surgery Follow‐up: ranged from 1 to 5 years	152 per 1000	49 per 1000 (21 to 112)	RR 0.32 (0.14 to 0.74)	264 (3 studies)	⊕⊕⊝⊝ low^1,2	‐
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BCVA: best‐corrected visual acuity; CI: confidence interval; IOP: intraocular pressure; logMAR: logarithm of the minimum angle of resolution; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Downgraded for limitations in the design and implementation of available studies suggesting high likelihood of bias (‐1); high likelihood that studies did not mask outcome assessors. ²Downgraded for high probability of reporting bias (‐1). ³Downgraded for imprecision (‐1): wide confidence intervals.

Summary of findings for the main comparison. Summary of findings for Ex‐PRESS

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Summary of findings 2. Summary of findings for Ologen

Ologen implanted during trabeculectomy compared with trabeculectomy alone for people with glaucoma
Patient or population: people with glaucoma, including open‐angle, angle‐closure, and uncontrolled IOP Settings: ophthalmic surgery Intervention: Ologen implanted during trabeculectomy Comparison: trabeculectomy alone
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Eyes (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	trabeculectomy alone	Ologen
Postoperative mean IOP at 1 year	The mean IOP in the trabeculectomy‐alone groups was 15.2 mm Hg, ranged from 11 to 19.3 mm Hg.	The mean IOP in the Ologen groups was 1.40 higher (0.57 lower to 3.38 higher)	‐	177 (5 studies)	⊕⊝⊝⊝ very low^1,2,3	Analyzed using the generic inverse method
Postoperative mean logMAR BCVA at 1 year	See comment.	See comment.	‐	‐	‐	Senthil 2013 reported BCVA for 32 eyes at 6 weeks post‐surgery: MD ‐0.24 logMAR, 95% CI ‐0.58 to 0.10
Complication as defined in protocol‐ Hypotony Follow‐up: ranged from 6 to 24 months	223 per 1000	167 per 1000 (105 to 265)	RR 0.75 (0.47 to 1.19)	233 (6 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Other complications reported by included studies
Shallow anterior chamber Follow‐up: ranged from 6 to 24 months	90 per 1000	71 per 1000 (29 to 174)	RR 0.79 (0.32 to 1.93)	213 (5 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Bleb leakage Follow‐up: ranged from 6 to 24 months	138 per 1000	117 per 1000 (46 to 304)	RR 0.85 (0.33 to 2.20)	129 (4 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Hyphema Follow‐up: ranged from 6 to 24 months	78 per 1000	114 per 1000 (40 to 327)	RR 1.46 (0.51 to 4.19)	229 (6 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Surgical revision Follow‐up: ranged from 6 to 24 months	40 per 1000	68 per 1000 (15 to 305)	RR 1.70 (0.38 to 7.63)	150 (4 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BCVA: best‐corrected visual acuity; CI: confidence interval; IOP: intraocular pressure; logMAR: logarithm of the minimum angle of resolution; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Downgraded for limitations in the design and implementation of available studies suggesting high likelihood of bias (‐1); high likelihood that studies did not mask outcome assessors. ²Downgraded for high probability of reporting bias (‐1). ³Downgraded for imprecision (‐1): wide confidence intervals.

Summary of findings 2. Summary of findings for Ologen

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Summary of findings 3. Summary of findings for amniotic membrane

Amniotic membrane implanted during trabeculectomy compared with trabeculectomy alone for people with glaucoma
Patient or population: people with glaucoma, including open‐angle, angle‐closure, uncontrolled IOP, and refractive glaucoma Settings: ophthalmic surgery Intervention: Amniotic membrane implanted during trabeculectomy Comparison: trabeculectomy alone
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Eyes (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	trabeculectomy alone	amniotic membrane
Postoperative mean IOP at 1 year	The mean IOP in the trabeculectomy alone groups was 17.6 mm Hg, ranged from 15.1 to 19.8 mm Hg.	The mean IOP in the Ologen groups was 3.92lower (5.41 lower to 2.42 lower)	‐	356 (9 studies)	⊕⊕⊝⊝ low^1,2
Postoperative mean logMAR BCVA at 1 year	See comment.	See comment.				Only 1 study reported this outcome; the amniotic membrane group had statistically significantly better BCVA than the trabeculectomy group, but no data for between‐group difference were provided
Complications ‐ Hypotony Follow‐up: ranged from 3 to 24 months	206 per 1000	82 per 1000 (35 to 193)	RR 0.40 (0.17 to 0.94)	205 (5 studies)	⊕⊕⊝⊝ low^1,3	‐
Other complications reported by included studies
Complications ‐ Shallow anterior chamber Follow‐up: ranged from 3 to 24 months	240 per 1000	113 per 1000 (72 to 175)	RR 0.47 (0.30 to 0.73)	632 (13 studies)	⊕⊕⊝⊝ low^1,2	‐
Complications ‐ Bleb leakage Follow‐up: ranged from 3 to 24 months	327 per 1000	91 per 1000 (32 to 258)	RR 0.28 (0.10 to 0.79)	98 (2 studies)	⊕⊕⊝⊝ low^1,2	‐
Complications ‐ Hyphema Follow‐up: ranged from 3 to 24 months	91 per 1000	39 per 1000 (12 to 122)	RR 0.43 (0.14 to 1.34)	235 (5 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
Complications ‐ Surgical revision Follow‐up: ranged from 3 to 24 months	See comment.	See comment.	‐	‐		None of the studies reported this outcome.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BCVA: best corrected visual acuity; CI: Confidence interval; IOP: intraocular pressure; logMAR: Logarithm of the Minimum Angle of Resolution; RR: Risk Ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Downgraded for limitations in the design and implementation of available studies suggesting high likelihood of bias (‐1); high likelihood that studies did not mask outcome assessors. ²Downgraded for high probability of reporting bias (‐1). ³Downgraded for imprecision (‐1): wide confidence intervals.

Summary of findings 3. Summary of findings for amniotic membrane

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Table 1. Summary of included studies

Device	Study ID	Study design	Country	Participant diagnosis	Interventions	Total number of participants randomized	Total number of eyes randomized	Total number of eyes analyzed	Longest follow‐up period (months)
Ex‐PRESS	Dahan 2012	RCT, paired‐eye design	South Africa	POAG	Trab + MMC Trab + MMC + Ex‐PRESS	15	30	30	12
	De Jong 2005 (abstract)	RCT, parallel‐group design	The Netherlands	OAG	Trab + Ex‐PRESS under a scleral flap Trab Trab + Ex‐PRESS under conjunctiva	109	120	N/A	6
	De Jong 2009	RCT, parallel‐group design	The Netherlands	OAG	Trab Trab + Ex‐PRESS	78	78	78	60
	Netland 2014	RCT, parallel‐group design	USA	OAG	Trab + MMC Trab + MMC + Ex‐PRESS	120	120	114	24
	Wagschal 2013	RCT, parallel‐group design	Canada	OAG, uncontrolled IOP	Trab + MMC Trab + MMC + Ex‐PRESS	64	64	60	12
	Subtotal for Ex‐PRESS					386	412	N/A	Range 6 to 60 months
Ologen	Cillino 2011	RCT, parallel‐group design	Italy	POAG, PEXG, uncontrolled IOP	Trab + MMC Trab + Ologen	40	40	40	24
	Maheshwari 2012	RCT, parallel‐group design	India	OAG	Trab + MMC Trab + Ologen	40	40	40	12
	Marey 2013	RCT, parallel‐group design	Egypt	POAG, ACG, PEXG, uveitic glaucoma, uncontrolled pseudophakic glaucoma	Trab + MMC Trab + Ologen	60	60	60	12
	Mitra 2012	RCT, parallel‐group design	India	Uncontrolled OAG	Trab + MMC Trab + Ologen	64	64	N/A	6
	Papaconstantinou 2010	RCT, parallel‐group design	Greece	glaucoma	Trab Trab + Ologen	40	40	40	6
	Rosentreter 2010	RCT, parallel‐group design	Germany	OAG, uncontrolled IOP	Trab + MMC Trab + Ologen	20	20	20	12
	Rosentreter 2014	RCT, parallel‐group design	Germany	OAG, uncontrolled IOP	Trab + MMC Trab + Ologen	30	30	30	12
	Senthil 2013	RCT, parallel‐group design	India	Uncontrolled POAG or PACG	Trab + MMC Trab + Ologen	33	39	32	24
	Subtotal for Ologen					327	333	N/A	Range 6 to 24 month
Amniotic membrane	Bruno 2008 (abstract)	RCT, parallel‐group design	N/A	OAG and failed surgery	Trab + MMC Trab + MMC + AMT	19	N/A	N/A	6
	Cai 2012	RCT, parallel‐group design	China	Refractory glaucoma	Trab Trab + AMT	40	48	48	12
	Cho 2013	RCT, parallel‐group design	China	POAG, ACG, uncontrolled IOP	Trab + MMC Trab + AMT	47	52	39	3
	Eliezer 2006	RCT, parallel‐group design	Brazil	POAG	Trab Trab + AMT	32	32	N/A	12
	Huang 2007	RCT, parallel‐group design	China	PACG	Trab Trab + AMT	50	63	N/A	6
	Ji 2013	RCT, paired‐eye design	China	Uncontrolled glaucoma	Trab Trab + AMT	17	34	N/A	24
	Khairy 2015	RCT, parallel‐group design	Egypt	OAG	Trab + MMC Trab + AMT	52	52	52	24
	Li 2010	RCT, parallel‐group design	China	Refractory glaucoma	Trab + MMC Trab + MMC + AMT	50	62	N/A	12
	Liu 2009	RCT, parallel‐group design	China	Refractory glaucoma	Trab + MMC Trab + MMC + AMT	35	35	32	12
	Ren 2009	RCT	China	ACG	Trab Trab + AMT	30	36	N/A	12
	Sheha 2008	RCT, parallel‐group design	Saudi Arabia	Refractory glaucoma	Trab + MMC Trab + MMC + AMT	37	37	30	12
	Stavrakas 2012	RCT	Greece	POAG, uncontrolled IOP	Trab Trab + AMT	50	59	52	24
	Wang 2008	RCT, parallel‐group design	China	glaucoma	Trab Trab + AMT	40	40	N/A	12
	Wang 2009	RCT	China	Refractory glaucoma	Trab Trab + MMC Trab + MMC + AMT	38	44	N/A	12
	Yan 2004	RCT	China	PACG	Trab Trab + AMT	52	63	63	6
	Yang 2004	RCT, parallel‐group design	China	glaucoma	Trab Trab + AMT	70	70	N/A	6
	Zhang 2009	RCT	China	ACG	Trab Trab + AMT	39	52	N/A	6
	Zheng 2005	RCT	China	POAG, PACG	Trab + MMC Trab + AMT	28	48	N/A	12
	Subtotal for amniotic membrane					726	N/A	N/A	Range 3 to 24 months
E‐PTFE	Cillino 2008	RCT, parallel‐group design	Italy	POAG, PEXG, uncontrolled IOP	Trab Trab + MMC Trab + E‐PTFE Trab + MMC + E‐PTFE	60	60	60	24
E‐PTFE	Subtotal for E‐PTFE					60	60	60	24
Gelfilm	Birt 1998 (abstract)	RCT, parallel‐group design	Not reported	Not reported	Trab Trab + Gelfilm Trab + MMC Trab + MMC + Gelfilm	43	N/A	N/A	12
Gelfilm	Subtotal for Gelfilm					43	N/A	N/A	12
Total for all included studies						1542	N/A	N/A	Range 3 months to 5 years
ACG: angle‐closure glaucoma AMT: amniotic membrane E‐PTFE: expanded polytetrafluoroethylene IOP: intraocular pressure MMC: mitomycin C N/A: not applicable OAG: open‐angle glaucoma PACG: primary angle‐closure glaucoma PEXG: pseudoexfoliation glaucoma POAG: primary open‐angle glaucoma RCT: randomized controlled trial

Table 1. Summary of included studies

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Comparison 1. Trabeculectomy (Trab) + Ex‐PRESS versus Trabeculectomy (Trab)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative IOP at one year Show forest plot	3	165	Mean Difference (IV, Fixed, 95% CI)	‐1.58 [‐2.74, ‐0.42]

2 Postoperative IOP at six months Show forest plot	3	205	Mean Difference (IV, Fixed, 95% CI)	0.18 [‐0.90, 1.26]

3 Postoperative IOP at two years Show forest plot	3	212	Mean Difference (IV, Fixed, 95% CI)	‐1.45 [‐2.52, ‐0.37]

4 Postoperative logMAR BCVA at one year Show forest plot	2	90	Mean Difference (IV, Fixed, 95% CI)	‐0.15 [‐0.40, 0.10]

5 Complications Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 Hypotony	2	94	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.63, 1.33]
5.2 Shallow/flat anterior chamber	4	294	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.40, 1.32]
5.3 Bleb leakage	4	294	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.50, 3.20]
5.4 Hyphema	4	294	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.12, 0.94]
5.5 Cataract surgery	3	264	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.14, 0.74]

Comparison 1. Trabeculectomy (Trab) + Ex‐PRESS versus Trabeculectomy (Trab)

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Comparison 2. Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 IOP at one year Show forest plot	5		Mean Difference (Random, 95% CI)	Subtotals only

1.1 Mean change of IOP from baseline to one year	2	44	Mean Difference (Random, 95% CI)	‐0.32 [‐5.88, 5.24]
1.2 Postoperative IOP at one year	5	177	Mean Difference (Random, 95% CI)	1.40 [‐0.57, 3.38]
2 Postoperative IOP at day one Show forest plot	5	162	Mean Difference (IV, Random, 95% CI)	0.51 [‐1.95, 2.97]

3 Postoperative IOP at six months Show forest plot	7		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 Change of IOP from baseline to six months	2	46	Mean Difference (IV, Random, 95% CI)	‐1.24 [‐6.23, 3.76]
3.2 Postoperative IOP at six months	5	236	Mean Difference (IV, Random, 95% CI)	0.43 [‐0.97, 1.84]
4 Postoperative IOP at two years Show forest plot	2	55	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐1.29, 1.69]

5 Complications Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 Hypotony	6	233	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.47, 1.19]
5.2 Surgical revision within 3 months	4	150	Risk Ratio (M‐H, Random, 95% CI)	1.70 [0.38, 7.63]
5.3 Blebitis or endophthalmitis	3	164	Risk Ratio (M‐H, Random, 95% CI)	1.57 [0.25, 9.70]
5.4 Bleb leakage	4	129	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.33, 2.20]
5.5 Hyphema	6	229	Risk Ratio (M‐H, Random, 95% CI)	1.46 [0.51, 4.19]
5.6 Choroidal detachment	4	129	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.33, 2.09]
5.7 Shallow anterior chamber	5	213	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.32, 1.93]
5.8 Anterior chamber reaction	2	99	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.56, 2.60]
5.9 Positive Seidel test	3	164	Risk Ratio (M‐H, Random, 95% CI)	1.93 [0.32, 11.54]
5.10 Tenon's cysts	3	124	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.21, 3.66]

Comparison 2. Trabeculectomy (Trab) + Ologen versus Trabeculectomy (Trab)

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Comparison 3. Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative IOP at one year Show forest plot	9	356	Mean Difference (IV, Random, 95% CI)	‐3.92 [‐5.41, ‐2.42]

1.1 with MMC in both groups	4	154	Mean Difference (IV, Random, 95% CI)	‐3.93 [‐4.91, ‐2.95]
1.2 without MMC in both groups	4	150	Mean Difference (IV, Random, 95% CI)	‐4.65 [‐7.79, ‐1.51]
1.3 with MMC in the trabeculectomy group only	1	52	Mean Difference (IV, Random, 95% CI)	‐0.30 [‐2.21, 1.61]
2 Postoperative IOP at one day Show forest plot	8		Mean Difference (IV, Random, 95% CI)	Totals not selected

2.1 with MMC in both groups	2		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 without MMC in both groups	4		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 with MMC in the trabeculectomy group only	2		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3 Postoperative IOP at one week Show forest plot	13		Mean Difference (IV, Random, 95% CI)	Totals not selected

3.1 with MMC in both groups	4		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 without MMC in both groups	6		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 with MMC in the trabeculectomy group only	3		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4 Postoperative IOP at one month Show forest plot	13	646	Mean Difference (IV, Random, 95% CI)	‐1.05 [‐1.96, ‐0.13]

4.1 with MMC in both groups	3	131	Mean Difference (IV, Random, 95% CI)	‐1.06 [‐1.84, ‐0.28]
4.2 without MMC in both groups	7	370	Mean Difference (IV, Random, 95% CI)	‐1.78 [‐3.65, 0.10]
4.3 with MMC in the trabeculectomy group only	3	145	Mean Difference (IV, Random, 95% CI)	0.44 [‐1.21, 2.09]
5 Postoperative IOP at three months Show forest plot	11	551	Mean Difference (IV, Random, 95% CI)	‐2.23 [‐2.93, ‐1.53]

5.1 with MMC in both groups	3	131	Mean Difference (IV, Random, 95% CI)	‐2.64 [‐3.50, ‐1.77]
5.2 without MMC in both groups	6	320	Mean Difference (IV, Random, 95% CI)	‐2.48 [‐3.89, ‐1.07]
5.3 with MMC in the trabeculectomy group only	2	100	Mean Difference (IV, Random, 95% CI)	‐0.76 [‐2.65, 1.14]
6 Postoperative IOP at six months Show forest plot	13	613	Mean Difference (IV, Random, 95% CI)	‐2.50 [‐3.34, ‐1.67]

6.1 with MMC in both groups	4	155	Mean Difference (IV, Random, 95% CI)	‐2.91 [‐3.87, ‐1.95]
6.2 without MMC in both groups	7	358	Mean Difference (IV, Random, 95% CI)	‐3.00 [‐4.52, ‐1.48]
6.3 with MMC in the trabeculectomy group only	2	100	Mean Difference (IV, Random, 95% CI)	0.14 [‐1.27, 1.55]
7 Postoperative IOP at two years Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 with MMC in the trabeculectomy group only	1	52	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐2.16, 1.76]
7.2 without MMC in both groups	1	34	Mean Difference (IV, Fixed, 95% CI)	‐2.96 [‐5.52, ‐0.40]
8 Complications Show forest plot	17		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 Hypotony	5	205	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.17, 0.94]
8.2 Shallow anterior chamber	13	632	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.30, 0.73]
8.3 Hyphema	5	235	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.14, 1.34]
8.4 Bleb leakage	2	98	Risk Ratio (M‐H, Random, 95% CI)	0.28 [0.10, 0.79]
8.5 Encapsulated blebs	5	175	Risk Ratio (M‐H, Random, 95% CI)	0.23 [0.08, 0.69]
8.6 Choroidal detachment	4	187	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.13, 1.71]

Comparison 3. Trabeculectomy (Trab) + AMT (amniotic membrane) versus Trabeculectomy (Trab)

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Comparison 4. Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative IOP at one year Show forest plot	1	60	Mean Difference (IV, Fixed, 95% CI)	‐0.44 [‐1.76, 0.88]

1.1 with MMC in both groups	1	30	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐1.58, 1.78]
1.2 without MMC in both groups	1	30	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐3.42, 0.82]
2 Hypotony at 24 months Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.11, 0.77]

2.1 with MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.14, 1.35]
2.2 without MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.02]
3 Hyphaema at 24 months Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.37, 1.74]

3.1 with MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.27, 2.41]
3.2 without MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.27, 2.41]
4 Inflammation at 24 months Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.4 [0.50, 3.91]

4.1 with MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.36, 4.97]
4.2 without MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.5 [0.29, 7.73]
5 Shallow anterior chamber at 24 months Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.15, 1.29]

5.1 with MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.11, 2.33]
5.2 without MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.4 [0.09, 1.75]
6 Flat anterior chamber at 24 months Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.6 [0.08, 4.28]

6.1 with MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.07, 14.55]
6.2 without MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.58]
7 Choroidal detachment at 24 months Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.43 [0.12, 1.51]

7.1 with MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.03, 1.98]
7.2 without MMC in both groups	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.13, 3.44]

Comparison 4. Trabeculectomy (Trab) + E‐PTFE versus Trabeculectomy (Trab)

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