Mitomycin C versus 5‐Fluorouracil for wound healing in glaucoma surgery

Emily Cabourne; Jonathan CK Clarke; Patricio G Schlottmann; Jennifer R Evans

doi:10.1002/14651858.CD006259.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

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 MMC versus 5‐FU, Outcome 1 Failure of functioning trabeculectomy at one year.

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Analysis 1.2

Comparison 1 MMC versus 5‐FU, Outcome 2 Failure of functioning trabeculectomy at one year in descending order of MMC exposure (dose x duration).

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Analysis 1.3

Comparison 1 MMC versus 5‐FU, Outcome 3 Failure of functioning trabeculectomy at one year depending on 5‐FU administration technique.

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Analysis 1.4

Comparison 1 MMC versus 5‐FU, Outcome 4 Intraocular pressure at one year.

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Analysis 1.5

Comparison 1 MMC versus 5‐FU, Outcome 5 Use of postoperative anti‐glaucoma medications at final follow up.

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Analysis 1.6

Comparison 1 MMC versus 5‐FU, Outcome 6 Mean number of postoperative anti‐glaucoma medications.

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Analysis 1.7

Comparison 1 MMC versus 5‐FU, Outcome 7 Loss of 2 or more lines of Snellen visual acuity postoperatively.

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Analysis 1.8

Comparison 1 MMC versus 5‐FU, Outcome 8 Postoperative Complications.

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Summary of findings for the main comparison. MMC compared to 5‐FU for wound healing in glaucoma surgery

MMC compared to 5‐FU for wound healing in glaucoma surgery
Patient or population: wound healing in glaucoma surgery Settings: Intervention: MMC Comparison: 5‐FU
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants/eyes (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	5‐FU	MMC
Failure of functioning trabeculectomy at 1 year	Study population		Low‐risk population RR 0.65 (95% CI 0.19 to 2.20) High‐risk population RR 0.49 (95% CI 0.22 to 1.08)	634 (11 RCTs: 6 including low‐risk population and 5 including high‐risk population)	⊕⊕⊝⊝ LOW ^1,2
	Low‐risk population: 74 per 1000 High‐risk population: 272 per 1000	Low‐risk population: 50 per 1000 High‐risk population: 137 per 1000
Intraocular pressure at 1 year	The mean intraocular pressure at 1 year ranged across 5‐FU groups. Low‐risk population: 10.9 to 14.3 mmHg High‐risk population: 14.8 to 16.3 mmHg	The mean intraocular pressure at 1 year in the MMC groups had a range of values. Low‐risk population: 9.9 to 11.6 mmHg High‐risk population: 8.6 to 13.7 mmHg	‐	386 (7 RCTs: 3 including low‐risk population and 4 including high‐risk population)	⊕⊕⊝⊝ LOW ^1,3
Loss of 2 or more lines of Snellen visual acuity at 1 year	Study population		Low‐risk population RR 2.00 (95% CI 0.53 to 7.59) High‐risk population RR 0.81 (95% CI 0.36 to 1.80)	328 (5 RCTs: 2 including low‐risk population and 3 including high‐risk population)	⊕⊕⊝⊝ LOW ^2,4
	Low‐risk population: 47 per 1000 High‐risk population: 115 per 1000	Low‐risk population: 94 per 1000 High‐risk population: 96 per 1000
Postoperative complications: late hypotony	Study population		RR 1.37 (95% CI 0.41 to 4.63)	211 (4 RCTs)	⊕⊕⊝⊝ LOW ^2,4
	37 per 1000	59 per 1000
Postoperative complications: choroidal detachment	Study population		RR 0.86 (95% CI 0.45 to 1.63)	494 (8 RCTs)	⊕⊕⊝⊝ LOW ^1,2
	68 per 1000	70 per 1000
Postoperative complications: endophthalmitis	Study population		RR 3.89 (95% CI 0.44 to 34.57)	315 (4 RCTs)	⊕⊕⊝⊝ LOW ^1,2
	0 per 1000	19 per 1000
Quality of life at 1 year						Not reported
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). 5‐FU: 5‐Fluorouracil; CI: confidence interval; MMC: mitomycin C; RCT: randomised controlled trial; 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 risk of bias: only one study at low risk of bias in all domains ²Downgraded for imprecision: wide confidence intervals ³Downgraded for inconsistency: I² = 60% ⁴Downgraded for risk of bias: no study at low risk of bias in all domains

Summary of findings for the main comparison. MMC compared to 5‐FU for wound healing in glaucoma surgery

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Table 1. Interventions

Study	MMC*			5‐FU
Study	Dose	Duration (minutes)	Location	Intraoperative or postoperative	Dose	Number of injections	Duration	Location
Katz 1995	0.5 mg/ml	5	Between the conjunctiva and the episclera	Postoperative	5 mg	10 (daily for 1 week, 3 times following week)	NA (injection)	Subconjunctival injection
Kitazawa 1991	0.4 mg/ml	5	Between the conjunctival and scleral flap	Postoperative	5 mg	10 (each day for 1 week and every other day for the following week)	NA (injection)	Subconjunctival injections, 90 to 180 degrees away from the surgical site
Lamping 1995	0.4 mg/ml	2.5	Between the conjunctival and scleral flap	Postoperative	5 mg	10 (first 10 days)	NA (injection)	Subconjunctival injection, 180 degrees from operating site
Mostafaei 2011	0.02 mg	not stated	Subconjunctival injection, 180 degrees away from operating site	Intraoperative	5 mg	NA	Not stated	Subconjunctival injection
Singh 1997	0.5 mg/ml	3.5	Between scleral flap and conjunctiva	Intraoperative	50 mg/ml	NA	5	Between scleral flap and conjunctiva
Singh 2000	0.4 mg/ml	2	Not stated	Intraoperative	50 mg/ml	NA	5	Not stated
Sisto 2007	0.2 mg/ml	2	Between the sclera and the Tenon's capsule	Postoperative	0.1 ml of 50 mg/ml	10 (starting on day 7, 2 injections per week for 2 weeks and then 1 injection per week for 6 weeks	NA (injection)	Subconjunctival injections near the bleb
Uva 1996	0.2 mg/ml	2	Between the sclera and the Tenon's capsule	Intraoperative	50 mg/ml	NA	5	Between the sclera and the Tenon's capsule
WuDunn 2002	0.2 mg/ml	2	Not stated	Intraoperative	50 mg/ml	NA	5	Not stated
Xinyu 2001	0.2 mg/ml	5	Not stated	Postoperative	5 mg	6 to 8 (alternate days, starting on day 3)	NA (injection)	Subconjunctival, 180 degrees away from the site of scleral flap
Zadok 1995	0.2 mg/ml	5	Between the conjunctiva and episclera	Postoperative	5 mg (0.5 ml of 10 mg/ml solution)	7 (once daily up to 7 times in the first week after surgery)	NA (injection)	Subconjunctival, 180 degrees from site of surgery
NA: not applicable * All MMC only one intraoperative application

Table 1. Interventions

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Comparison 1. MMC versus 5‐FU

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Failure of functioning trabeculectomy at one year Show forest plot	11	634	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.30, 1.00]

1.1 Low risk of failure	6	370	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.19, 2.20]
1.2 High risk of failure	5	264	Risk Ratio (M‐H, Random, 95% CI)	0.49 [0.22, 1.08]
2 Failure of functioning trabeculectomy at one year in descending order of MMC exposure (dose x duration) Show forest plot	10	594	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.30, 1.00]

3 Failure of functioning trabeculectomy at one year depending on 5‐FU administration technique Show forest plot	10	594	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.30, 1.00]

3.1 5‐FU by postoperative injections	6	273	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.27, 1.15]
3.2 5‐FU by intraoperative sponge application	4	321	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.13, 2.08]
4 Intraocular pressure at one year Show forest plot	7	386	Mean Difference (IV, Random, 95% CI)	‐3.05 [‐4.60, ‐1.50]

4.1 Low risk of failure	3	162	Mean Difference (IV, Random, 95% CI)	‐1.72 [‐3.28, ‐0.16]
4.2 High risk of failure	4	224	Mean Difference (IV, Random, 95% CI)	‐4.18 [‐6.73, ‐1.64]
5 Use of postoperative anti‐glaucoma medications at final follow up Show forest plot	7	426	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.57, 1.85]

5.1 Low risk of failure	4	273	Risk Ratio (M‐H, Random, 95% CI)	1.11 [0.60, 2.07]
5.2 High risk of failure	3	153	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.26, 3.76]
6 Mean number of postoperative anti‐glaucoma medications Show forest plot	4	342	Mean Difference (IV, Random, 95% CI)	‐0.33 [‐0.70, 0.05]

6.1 Low risk of failure	2	223	Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.27, 0.11]
6.2 High risk of failure	2	119	Mean Difference (IV, Random, 95% CI)	‐0.71 [‐1.34, ‐0.09]
7 Loss of 2 or more lines of Snellen visual acuity postoperatively Show forest plot	5	328	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.54, 2.06]

7.1 Low risk of failure	2	128	Risk Ratio (M‐H, Fixed, 95% CI)	2.0 [0.53, 7.59]
7.2 High risk of failure	3	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.36, 1.80]
8 Postoperative Complications Show forest plot	11		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 Bleb leak	2	154	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.32, 4.68]
8.2 Wound leak	6	391	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.51, 2.71]
8.3 Late hypotony	4	211	Risk Ratio (M‐H, Random, 95% CI)	1.37 [0.41, 4.63]
8.4 Maculopathy	4	342	Risk Ratio (M‐H, Random, 95% CI)	1.71 [0.35, 8.33]
8.5 Cataract	4	275	Risk Ratio (M‐H, Random, 95% CI)	1.73 [0.65, 4.61]
8.6 Shallow anterior chamber	5	311	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.67, 2.21]
8.7 Choroidal detachment	8	494	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.45, 1.63]
8.8 Epitheliopathy	8	419	Risk Ratio (M‐H, Random, 95% CI)	0.23 [0.11, 0.47]
8.9 Tenon cyst	3	177	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.20, 4.38]
8.10 Hyphaema	4	250	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.42, 0.91]
8.11 Suprachoroidal haemorrhage	3	303	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.09, 5.66]
8.12 Endophthalmitis	4	315	Risk Ratio (M‐H, Random, 95% CI)	3.89 [0.44, 34.57]

Comparison 1. MMC versus 5‐FU

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