Cyclodestructive procedures for non‐refractory glaucoma

Manuele Michelessi; Amanda K Bicket; Kristina Lindsley

doi:10.1002/14651858.CD009313.pub2

Prosedur siklodestruktif untuk glaukoma bukan refraktori

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Referencias

References to studies included in this review

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estudios excluidos
otras referencias
otras versiones publicadas

Egbert PR, Fiadoyor S, Budenz DL, Dadzie P, Byrd S. Diode laser transscleral cyclophotocoagulation as a primary surgical treatment for primary open‐angle glaucoma. Archives of Ophthalmology 2001;119(3):345‐50.

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References to studies excluded from this review

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estudios incluidos
otras referencias
otras versiones publicadas

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References to other published versions of this review

Ir a:

estudios incluidos
estudios excluidos
otras referencias

Jones L, Smith O, Yousuf SJ, Kwagyan J. Cyclodestructive procedures for glaucoma. Cochrane Database of Systematic Reviews 2011, Issue 9. [DOI: 10.1002/14651858.CD009313]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

estudios excluidos

Egbert 2001

Methods	Study design: parallel‐group, randomized controlled trial Number randomized (total and by group): Total: 92 eyes of 92 participants By group: 47 participants (Group 1, 1.5 W for 1.5 seconds) and 45 participants (Group 2, 1.25 W for 2.5 seconds) Exclusions after randomization: none reported Number analyzed (total and by group): Total: 79 eyes of 79 participants By group: 40 participants (Group 1) and 39 participants (Group 2) Unit of analysis: individual, 1 eye per person (worse eye if both eyes eligible) Losses to follow‐up: 13 of 92 participants (14%) How were missing data handled?: excluded from analysis Sample size calculation: not reported
Participants	Country: Ghana (Cape Coast and Accra) Mean age: 60.9 years Gender (number and percent): 56 (61%) men and 36 (39%) women Inclusion criteria: older than 20 years and having a diagnosis of primary open‐angle glaucoma (diagnosed by elevated IOP and glaucomatous disc cupping; exam also included gonioscopy, but not visual field testing) Exclusion criteria: previous glaucoma surgery, including argon laser trabeculoplasty, cataract extraction, or any other ocular surgery, or having no light perception Diagnosis: participants had “very advanced” primary open‐angle glaucoma; treated eye was the eye with more advanced glaucoma
Interventions	Group 1: 1.5 W for 1.5 seconds x 20 spots over 360 ° (45.0 J) Group 2: 1.25 W for 2.5 seconds x 20 spots over 360 ° (62.5 J) Retreatment: retreatment was at the discretion of the treating ophthalmologist; repeat treatment followed the original settings, but was limited to 15 spots over 270 ° Postoperative care: 4 mg of dexamethasone phosphate given subconjunctivally; atropine sulfate 1% applied twice daily and topical steroid applied 4 times daily; for a minimum of 3 weeks or until postoperative iritis resolved; use of glaucoma medications pre‐ or postoperatively was not standardized and may have been associated with variations in compliance Laser: OucLight SLx diode laser with a handheld G‐probe (IRIS Medical Instruments, Mountain View, California) Length of follow‐up: Planned: not reported Actual: mean 13.2 months; analysis included only participants with at least 3 months follow‐up
Outcomes	Primary outcome, as defined in study reports: (1) change in IOP and (2) reduction of medications Secondary outcomes, as defined in study reports: (1) change in visual acuity and (2) complications Adverse events reported: yes Intervals at which outcomes assessed: 1 day, 1 week, 3 weeks, and every 2 to 3 months
Notes	Trial registration: not reported Funding sources: Elsie B. Ballantyne Fund, Department of Ophthalmology, Standford University. IRIS Medical Instruments supplied the laser used in the study Disclosures of interest: not reported Study period: treatments administered February to August 1997 Reported subgroup analyses: none between treatment groups (only for total study population)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “We randomly assigned patients to receive 1 of 2 energy settings. After the retrobulbar anesthesia and just before treatment, a nurse tossed the coin to determine the settings.”
Allocation concealment (selection bias)	Low risk	Quote: “After the retrobulbar anesthesia and just before treatment, a nurse tossed the coin to determine the settings.” Participants were randomized while under anesthesia, so allocation would not have been known prior to enrollment in the trial
Masking of participants and personnel (performance bias)	Unclear risk	No information provided on masking of participants or personnel
Masking of outcome assessment (detection bias)	High risk	Quote: “Examiners were not masked to the treatment.”
Incomplete outcome data (attrition bias) All outcomes	High risk	13 (14%) of 92 participants were excluded from analysis for all outcome measures, except for complications. In comparing those who were followed up for 3 months (and were included) with those who were not (excluded), the excluded were more likely to be male and more than 50 years old; preoperative IOP was similar between the 2 groups, but no postoperative IOP values were available. Comparisons between the treatment groups were not made for those that were not included in the analysis
Selective reporting (reporting bias)	Low risk	Results were reported for all outcomes specified in the Methods section of published report
Other bias	Unclear risk	The laser used in the trial was provided by the manufacturer. The trial was not registered prospectively.

IOP: intraocular pressure
J: joule
mg: milligram
W: watts

Characteristics of excluded studies [ordered by study ID]

Ir a:

estudios incluidos

Study	Reason for exclusion
Agarwal 2004	Refractory glaucoma: RCT of 60 eyes with refractory glaucoma treated with contact versus non‐contact diode transscleral cyclophotocoagulation
Alves 1997	Case series: 18 eyes with neovascular glaucoma treated with contact diode transscleral cyclophotocoagulation
Alves 2003	Cohort study: 21 eyes with neovascular glaucoma treated with diode transscleral cyclophotocoagulation with laser on the ciliary body only; compared to a cohort of 21 eyes treated with diode transscleral cyclophotocoagulation with ablation of periphery retina
Ando 1990	Case series: 21 eyes with refractory glaucoma treated with continuous wave Nd:YAG cyclophotocoagulation using an artificial sapphire crystal contact probe
Aquino 2015	Refractory glaucoma: RCT of 48 eyes with refractory glaucoma treated with micropulse versus continuous wave diode transscleral cyclophotocoagulation
Berke 2006	Cohort study: 626 eyes with cataract and medically‐controlled glaucoma treated with phacoemulsification plus endoscopic cyclophotocoagulation; compared to a cohort of 81 eyes treated with phacoemulsification alone (conference abstract only, no full‐length report)
Brooks 1993	Refractory glaucoma: RCT of 31 eyes with intractable glaucoma treated with Nd:YAG cyclophotocoagulation versus cyclocryotherapy (conference abstract only, no full‐length report)
Cellini 1994	Case series: 10 eyes with neovascular glaucoma treated with semiconductor contact diode transscleral cyclophotocoagulation
Chalam 1999	Case series: 36 eyes with neovascular glaucoma treated with Nd:YAG transscleral cyclophotocoagulation or pneumatically stented pars plana Baerveldt implants (conference abstract only, no full‐length report)
Chalam 2001	Case series: 54 eyes with neovascular glaucoma treated with Nd:YAG transscleral cyclophotocoagulation, endocyclophotocoagulation, or pars plana Baerveldt implants (conference abstract only, no full‐length report)
Colvin Trucco 1995	Cohort study: 7 eyes with refractory glaucoma treated with diode transscleral cyclophotocoagulation at 1.2 W for 3.5 seconds (4.25 J); compared to a cohort of 7 eyes treated with diode transscleral cyclophotocoagulation at 2.8 W for 1.5 seconds (4.25 J)
Crymes 1990	Refractory glaucoma: RCT of 40 eyes with refractory glaucoma treated with noncontact Nd:YAG transscleral cyclophotocoagulation applied 1.5 versus 3.0 millimeters posterior to the corneoscleral limbus
Fankhauser 1993	Letter to editor: discussion of diode versus Nd:YAG lasers for cyclophotocoagulation
Gaasterland 1992	Case series: 21 eyes with refractory glaucoma treated with diode transscleral cyclophotocoagulation
Goldenberg‐Cohen 2005	Cohort study: 32 eyes with refractory glaucoma treated with diode transscleral cyclophotocoagulation; compared to a cohort of 38 eyes treated with cyclocryotherapy
Janknecht 2005	Cohort study: 28 eyes with cataract and glaucoma treated with phacoemulsification plus cyclophotocoagulation; compared to a cohort of 28 eyes treated with phacoemulsification alone
Kato 1997	Cohort study: 22 eyes with diabetic neovascular glaucoma treated with diode transscleral cyclophotocoagulation; compared to a cohort of 16 eyes treated with cyclocryotherapy
Koraszewska‐Matuszewska 2004	Cohort study: 29 eyes of children with secondary glaucoma treated with diode transscleral cyclophotocoagulation; compared to a cohort of 40 eyes treated with cyclocryotherapy
Korte 2002	Refractory glaucoma: RCT of 26 eyes with refractory glaucoma treated with cyclophotocoagulation versus cyclocryotherapy (conference abstract only, no full‐length report)
Liu 2008	Refractory glaucoma: RCT of 72 eyes with refractory glaucoma treated with diode transscleral cyclophotocoagulation versus cyclocryotherapy
Marcus 1992	Refractory glaucoma: RCT of 45 eyes with refractory glaucoma treated with 180 ° versus 360 ° Nd:YAG transscleral cyclophotocoagulation (conference abstract only, no full‐length report)
Miller‐Meeks 1994	Refractory glaucoma: RCT of 22 eyes with uncontrolled glaucoma treated with 7 W versus 9 W Nd:YAG transscleral cyclophotocoagulation (conference abstract only, no full‐length report)
Montanari 1997	Case series: 14 eyes with refractory glaucoma treated with diode transscleral cyclophotocoagulation
Shields 1993	Refractory glaucoma: RCT of 89 eyes with intractable glaucoma treated with 4 J versus 8 J noncontact Nd:YAG transscleral cyclophotocoagulation
Walland 1998	Refractory glaucoma: RCT of 30 eyes with end‐stage glaucoma treated with half‐ versus full‐dose diode transscleral cyclophotocoagulation
Yildirim 2009	Refractory glaucoma: RCT of 66 eyes with neovascular glaucoma treated with contact diode transscleral cyclophotocoagulation versus Ahmed glaucoma valve implant
Zhang 2010	Cohort study: 25 eyes with neovascular glaucoma treated with transscleral cyclophotocoagulation; compared to a cohort of 18 eyes treated with cyclocryotherapy

J: joule
Nd:YAG: neodymium:yttrium‐alluminum‐garnet
RCT: randomized controlled trial
W: watts

Figure 1

Study flow diagram.

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Summary of findings for the main comparison. Low‐ versus high‐energy diode trans‐scleral cyclophotocoagulation for non‐refractory glaucoma

Low‐ versus high‐energy diode transscleralcyclophotocoagulation for non‐refractory glaucoma
Population: people with primary open‐angle glaucoma and no previous glaucoma surgery Settings: ophthalmology clinics Intervention: low energy; 1.5 watts for 1.5 seconds x 20 spots over 360 ° (45.0 J) Comparison: high energy; 1.25 watts for 2.5 seconds x 20 spots over 360 ° (62.5 J)
Outcomes*	Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	High‐energy diode transscleralcyclophotocoagulation	Low‐energy diode transscleralcyclophotocoagulation
Control of intraocular pressure	462 per 1000	475 per 1000 (295 to 762)	RR 1.03 (0.64 to 1.65)	79 (1 study)	⊕⊕⊝⊝ low^{1, 2}	Control of intraocular pressure defined as a decrease in IOP by 20% from baseline value
Mean change in intraocular pressure	On average intraocular pressure in the high energy group dropped by 3 mmHg	On average intraocular pressure in the low‐energy group was 0.5 mmHg lower than the IOP in the high‐energy group (5.79 mmHg lower to 4.79 mmHg higher)	‐	79 (1 study)	⊕⊕⊝⊝ low^{1, 2}	‐
Decrease in visual acuity	205 per 1000	250 per 1000 (111 to 566)	RR 1.22 (0.54 to 2.76)	79 (1 study)	⊕⊕⊝⊝ low^{1, 2}	Decrease in visual acuity defined as a decrease of 2 or more lines on the Snellen chart or one or more categories of visual acuity if unable to read the eye chart
Mean visual field	No visual field outcomes reported	‐	‐	‐	‐	‐
Number of glaucoma medications after treatment	The mean number of glaucoma medications in the high energy group was 1.3	The mean number of glaucoma medications in the low energy group was 0.10 more (0.43 fewer to 0.63 more)	‐	79 (1 study)	⊕⊕⊕⊝ moderate¹	‐
Additional glaucoma surgery	231 per 1000	175 per 1000 (72 to 425)	RR 0.76 (0.31 to 1.84)	79 (1 study)	⊕⊕⊝⊝ low^{1, 2}	Additional glaucoma surgery defined as retreatment with cyclophotocoagulation according to randomized assignment
Adverse events: atonic pupil	311 per 1000	277 per 1000 (146 to 523)	RR 0.89 (0.47 to 1.68)	92 (1 study)	⊕⊕⊝⊝ low^{1, 2}	Atonic pupil was the only adverse event reported by treatment group. Trial authors noted that most participants had mild to moderate pain for a few days following the procedure and many also had transient conjunctival burns (number not reported). Severe iritis occurred in 2 eyes and hyphema occurred in 3 eyes. No instances of hypotony or phthisis bulbi were reported
All outcomes are reported for participants with at least 3 months follow‐up; mean follow‐up was 13.2 months. The basis for the assumed risk* is the risk in the comparison group. 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). J: joule; CI: confidence interval; RR: risk ratio; mmHg: millimeter of mercury
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 in the trial (unmasked outcome assessors and 14% attrition). ²Downgraded for imprecision in the effect estimate (wide confidence interval).

Summary of findings for the main comparison. Low‐ versus high‐energy diode trans‐scleral cyclophotocoagulation for non‐refractory glaucoma

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Referencias

References to studies included in this review

Egbert 2001 {published data only}

References to studies excluded from this review

Agarwal 2004 {published data only}

Alves 1997 {published data only}

Alves 2003 {published data only}

Ando 1990 {published data only}

Aquino 2015 {published data only}

Berke 2006 {published data only}

Brooks 1993 {published data only}

Cellini 1994 {published data only}

Chalam 1999 {published data only}

Chalam 2001 {published data only}

Colvin Trucco 1995 {published data only}

Crymes 1990 {published data only}

Fankhauser 1993 {published data only}

Gaasterland 1992 {published data only}

Goldenberg‐Cohen 2005 {published data only}

Janknecht 2005 {published data only}

Kato 1997 {published data only}

Koraszewska‐Matuszewska 2004 {published data only}

Korte 2002 {published data only}

Liu 2008 {published data only}

Marcus 1992 {published data only}

Miller‐Meeks 1994 {published data only}

Montanari 1997 {published data only}

Shields 1993 {published data only}

Walland 1998 {published data only}

Yildirim 2009 {published data only}

Zhang 2010 {published data only}

Additional references

AGIS 2000

Ansari 2007

Bechrakis 1994

Beckman 1972

Bloom 1997

Burr 2012

Chen 2016

CNTGS 1998

Coleman 1985

Coleman 2004

Edward 1989

EGS 2014

Friedman 2004

Garway‐Heath 2015

Glanville 2006

GRADEpro GDT [Computer program]

Hauber 2002

Hennis 2007

Higgins 2011

Ismail 2016

Lam 1992

Leske 2003

Lichter 2001

Lin 2008

Liu 1994

Meyer 1948

Murphy 2003

Pastor 1993

Pastor 2001

Quigley 1996

Quigley 2006

Review Manager 2014 [Computer program]

Sinchai 2008

Tham 2014

Topouzis 2008

Tseng 2017

Tóth 2017

Weih 2001

References to other published versions of this review

Jones 2011

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

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