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Meta-Analysis
. 2020 Aug 25;8(8):CD008213.
doi: 10.1002/14651858.CD008213.pub3.

Surgical interventions for primary congenital glaucoma

Meghal Gagrani  1 , Itika Garg  2 , Deepta Ghate  1
Affiliations
Meta-Analysis

Surgical interventions for primary congenital glaucoma

Meghal Gagrani et al. Cochrane Database Syst Rev. .

Abstract

Background: Primary congenital glaucoma (PCG) is an optic neuropathy with high intraocular pressure (IOP) that manifests within the first few years of a child's life and is not associated with other systemic or ocular abnormalities. PCG results in considerable morbidity even in high-income countries.

Objectives: To compare the effectiveness and safety of different surgical techniques for PCG.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2020, Issue 4); Ovid MEDLINE; Embase.com; PubMed; metaRegister of Controlled Trials (mRCT) (last searched 23 June 2014); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search. We last searched the electronic databases on 27 April 2020.

Selection criteria: We included randomized controlled trials (RCTs) and quasi-RCTs comparing different surgical interventions in children under five years of age with PCG.

Data collection and analysis: We used standard Cochrane methodology.

Main results: We included 16 trials (13 RCTs and three quasi-RCTs) with 587 eyes in 446 children. Eleven (69%) trials were conducted in Egypt and the Middle East, three in India, and two in the USA. All included trials involved children younger than five years of age, with follow-up ranging from six to 80 months. The interventions compared varied across trials. Three trials (on 68 children) compared combined trabeculotomy and trabeculectomy (CTT) with trabeculotomy. Meta-analysis of these trials suggests there may be little to no evidence of a difference between groups in mean IOP (mean difference (MD) 0.27 mmHg, 95% confidence interval (CI) -0.74 to 1.29; 88 eyes; 2 studies) and surgical success (risk ratio (RR) 1.01, 95% CI 0.90 to 1.14; 102 eyes; 3 studies) at one year postoperatively. We assessed the certainty of evidence as very low for these outcomes, downgrading for risk of bias (-1) and imprecision (-2). Hyphema was the most common adverse outcome in both groups (no meta-analysis due to considerable heterogeneity; I2 = 83%). Two trials (on 39 children) compared viscotrabeculotomy to conventional trabeculotomy. Meta-analysis of 42 eyes suggests there is no evidence of between groups difference in mean IOP (MD -1.64, 95% CI -5.94 to 2.66) and surgical success (RR 1.11, 95% CI 0.70 to 1.78) at six months postoperatively. We assessed the certainty of evidence as very low, downgrading for risk of bias and imprecision due to small sample size. Hyphema was the most common adverse outcome (38% in viscotrabeculotomy and 28% in conventional trabeculotomy), with no evidence of difference difference (RR 1.33, 95% CI 0.63 to 2.83). Two trials (on 95 children) compared microcatheter-assisted 360-degree circumferential trabeculotomy to conventional trabeculotomy. Meta-analysis of two trials suggests that mean IOP may be lower in the microcatheter group at six months (MD -2.44, 95% CI -3.69 to -1.19; 100 eyes) and at 12 months (MD -1.77, 95% CI -2.92 to -0.63; 99 eyes); and surgical success was more likely to be achieved in the microcatheter group compared to the conventional trabeculotomy group (RR 1.59, 95% CI 1.14 to 2.21; 60 eyes; 1 trial at 6 months; RR 1.54, 95% CI 1.20 to 1.97; 99 eyes; 2 trials at 12 months). We assessed the certainty of evidence for these outcomes as moderate due to small sample size. Hyphema was the most common adverse outcome (40% in the microcatheter group and 17% in the conventional trabeculotomy group), with greater likelihood of occurring in the microcatheter group (RR 2.25, 95% CI 1.25 to 4.04); the evidence was of moderate certainty due to small sample size (-1). Of the nine remaining trials, no two trials compared the same two surgical interventions: one trial compared CTT versus CTT with sclerectomy; three trials compared various suturing techniques and adjuvant use including mitomycin C, collagen implant in CTT; one trial compared CTT versus Ahmed valve implant in previously failed surgeries; one trial compared CTT with trabeculectomy; one trial compared trabeculotomy to goniotomy; and two trials compared different types of goniotomy. No trials reported quality of life or economic data. Many of the included trials had limitations in study design, implementation, and reporting, therefore the reliability and applicability of the evidence remains unclear.

Authors' conclusions: The evidence suggests that there may be little to no evidence of difference between CTT and routine conventional trabeculotomy, or between viscotrabeculotomy and routine conventional trabeculotomy. A 360-degree circumferential trabeculotomy may show greater surgical success than conventional trabeculotomy. Considering the rarity of the disease, future research would benefit from a multicenter, possibly international trial, involving parents of children with PCG and with a follow-up of at least one year.

PubMed Disclaimer

Conflict of interest statement

Meghal Gagrani: None known. Itika Garg: None known. Deepta Ghate: None known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 11 Combined trabeculotomy with trabeculectomy (CTT) versus trabeculotomy, outcome: 11.1 Mean change in IOP after surgery.
4
4
Forest plot of comparison: 1 Combined trabeculotomy with trabeculectomy (CTT) versus trabeculotomy, outcome: 1.2 Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications.
5
5
Forest plot of comparison: 1 Combined trabeculotomy with trabeculectomy (CTT) versus trabeculotomy, outcome: 1.4 Mean cup/disc ratio.
6
6
Forest plot of comparison: 1 Combined trabeculotomy with trabeculectomy (CTT) versus trabeculotomy, outcome: 1.5 Adverse outcomes (more than 3 included trials).
7
7
Forest plot of comparison: 2 Viscotrabeculotomy versus trabeculotomy, outcome: 2.1 Mean/mean change in IOP after surgery.
8
8
Forest plot of comparison: 2 Viscotrabeculotomy versus trabeculotomy, outcome: 2.3 Mean corneal diameter.
9
9
Forest plot of comparison: 2 Viscotrabeculotomy versus trabeculotomy, outcome: 2.6 Adverse outcomes.
10
10
Forest plot of comparison: 3 Microcatheter‐assisted trabeculotomy versus conventional trabeculotomy, outcome: 3.1 Mean IOP after surgery.
11
11
Forest plot of comparison: 3 Microcatheter‐assisted trabeculotomy versus conventional trabeculotomy, outcome: 3.2 Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications.
12
12
Forest plot of comparison: 3 Microcatheter‐assisted trabeculotomy versus conventional trabeculotomy, outcome: 3.7 Adverse outcomes.
1.1
1.1. Analysis
Comparison 1: Combined trabeculotomy with trabeculectomy versus trabeculotomy, Outcome 1: Mean IOP after surgery
1.2
1.2. Analysis
Comparison 1: Combined trabeculotomy with trabeculectomy versus trabeculotomy, Outcome 2: Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications
1.3
1.3. Analysis
Comparison 1: Combined trabeculotomy with trabeculectomy versus trabeculotomy, Outcome 3: Mean corneal diameter
1.4
1.4. Analysis
Comparison 1: Combined trabeculotomy with trabeculectomy versus trabeculotomy, Outcome 4: Mean cup/disc ratio
1.5
1.5. Analysis
Comparison 1: Combined trabeculotomy with trabeculectomy versus trabeculotomy, Outcome 5: Adverse outcomes (more than 3 included trials)
1.6
1.6. Analysis
Comparison 1: Combined trabeculotomy with trabeculectomy versus trabeculotomy, Outcome 6: Adverse outcomes (more than 3 included trials) without combing data
1.7
1.7. Analysis
Comparison 1: Combined trabeculotomy with trabeculectomy versus trabeculotomy, Outcome 7: Adverse outcomes (fewer than 3 included trials)
2.1
2.1. Analysis
Comparison 2: Viscotrabeculotomy versus trabeculotomy, Outcome 1: Mean/mean change in IOP after surgery
2.2
2.2. Analysis
Comparison 2: Viscotrabeculotomy versus trabeculotomy, Outcome 2: Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications
2.3
2.3. Analysis
Comparison 2: Viscotrabeculotomy versus trabeculotomy, Outcome 3: Mean corneal diameter
2.4
2.4. Analysis
Comparison 2: Viscotrabeculotomy versus trabeculotomy, Outcome 4: Mean number of glaucoma medications needed after surgery. We did not consider the use of glaucoma medications to maintain IOP as surgical failure if the IOP was ≤ 21 mmHg.
2.5
2.5. Analysis
Comparison 2: Viscotrabeculotomy versus trabeculotomy, Outcome 5: Mean cup/disc ratio
2.6
2.6. Analysis
Comparison 2: Viscotrabeculotomy versus trabeculotomy, Outcome 6: Adverse outcomes
3.1
3.1. Analysis
Comparison 3: Microcatheter‐assisted trabeculotomy group versus conventional trabeculotomy, Outcome 1: Mean IOP after surgery
3.2
3.2. Analysis
Comparison 3: Microcatheter‐assisted trabeculotomy group versus conventional trabeculotomy, Outcome 2: Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications
3.3
3.3. Analysis
Comparison 3: Microcatheter‐assisted trabeculotomy group versus conventional trabeculotomy, Outcome 3: Mean corneal diameter
3.4
3.4. Analysis
Comparison 3: Microcatheter‐assisted trabeculotomy group versus conventional trabeculotomy, Outcome 4: Proportion of children needing repeat surgery, defined as any glaucoma surgery required in the study eye to achieve surgical success excluding corneal (e.g. penetrating keratoplasty), cataract, or retinal surgeries
3.5
3.5. Analysis
Comparison 3: Microcatheter‐assisted trabeculotomy group versus conventional trabeculotomy, Outcome 5: Mean number of glaucoma medications needed after surgery. We did not consider the use of glaucoma medications to maintain IOP as surgical failure if the IOP was ≤ 21 mmHg.
3.6
3.6. Analysis
Comparison 3: Microcatheter‐assisted trabeculotomy group versus conventional trabeculotomy, Outcome 6: Mean cup/disc ratio
3.7
3.7. Analysis
Comparison 3: Microcatheter‐assisted trabeculotomy group versus conventional trabeculotomy, Outcome 7: Adverse outcomes
4.1
4.1. Analysis
Comparison 4: Trabeculotomy‐trabeculectomy plus mitomycin C with regular suture versus trabeculotomy‐trabeculectomy plus mitomycin C with releaseable suture, Outcome 1: Mean IOP after surgery
4.2
4.2. Analysis
Comparison 4: Trabeculotomy‐trabeculectomy plus mitomycin C with regular suture versus trabeculotomy‐trabeculectomy plus mitomycin C with releaseable suture, Outcome 2: Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications
4.3
4.3. Analysis
Comparison 4: Trabeculotomy‐trabeculectomy plus mitomycin C with regular suture versus trabeculotomy‐trabeculectomy plus mitomycin C with releaseable suture, Outcome 3: Mean corneal diameter
4.4
4.4. Analysis
Comparison 4: Trabeculotomy‐trabeculectomy plus mitomycin C with regular suture versus trabeculotomy‐trabeculectomy plus mitomycin C with releaseable suture, Outcome 4: Mean axial length
4.5
4.5. Analysis
Comparison 4: Trabeculotomy‐trabeculectomy plus mitomycin C with regular suture versus trabeculotomy‐trabeculectomy plus mitomycin C with releaseable suture, Outcome 5: Proportion of children needing repeat surgery, defined as any glaucoma surgery required in the study eye to achieve surgical success excluding corneal (e.g. penetrating keratoplasty), cataract, or retinal surgeries
4.6
4.6. Analysis
Comparison 4: Trabeculotomy‐trabeculectomy plus mitomycin C with regular suture versus trabeculotomy‐trabeculectomy plus mitomycin C with releaseable suture, Outcome 6: Mean cup/disc ratio
5.1
5.1. Analysis
Comparison 5: Trabeculotomy–trabeculectomy plus mitomycin C for 1 minute versus trabeculotomy–trabeculectomy plus mitomycin C for 2 minutes, Outcome 1: Mean IOP after surgery
5.2
5.2. Analysis
Comparison 5: Trabeculotomy–trabeculectomy plus mitomycin C for 1 minute versus trabeculotomy–trabeculectomy plus mitomycin C for 2 minutes, Outcome 2: Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications
5.3
5.3. Analysis
Comparison 5: Trabeculotomy–trabeculectomy plus mitomycin C for 1 minute versus trabeculotomy–trabeculectomy plus mitomycin C for 2 minutes, Outcome 3: Mean corneal diameter
5.4
5.4. Analysis
Comparison 5: Trabeculotomy–trabeculectomy plus mitomycin C for 1 minute versus trabeculotomy–trabeculectomy plus mitomycin C for 2 minutes, Outcome 4: Mean axial length
5.5
5.5. Analysis
Comparison 5: Trabeculotomy–trabeculectomy plus mitomycin C for 1 minute versus trabeculotomy–trabeculectomy plus mitomycin C for 2 minutes, Outcome 5: Mean cup/disc ratio
6.1
6.1. Analysis
Comparison 6: Trabeculotomy‐trabeculectomy plus collagen matrix implant versus trabeculotomy‐trabeculectomy plus mitomycin C, Outcome 1: Mean IOP after surgery
6.2
6.2. Analysis
Comparison 6: Trabeculotomy‐trabeculectomy plus collagen matrix implant versus trabeculotomy‐trabeculectomy plus mitomycin C, Outcome 2: Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications
6.3
6.3. Analysis
Comparison 6: Trabeculotomy‐trabeculectomy plus collagen matrix implant versus trabeculotomy‐trabeculectomy plus mitomycin C, Outcome 3: Mean corneal diameter
6.4
6.4. Analysis
Comparison 6: Trabeculotomy‐trabeculectomy plus collagen matrix implant versus trabeculotomy‐trabeculectomy plus mitomycin C, Outcome 4: Adverse outcomes
7.1
7.1. Analysis
Comparison 7: Trabeculotomy‐trabeculectomy versus Ahmed valve implantation, Outcome 1: Mean IOP after surgery
7.2
7.2. Analysis
Comparison 7: Trabeculotomy‐trabeculectomy versus Ahmed valve implantation, Outcome 2: Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications
7.3
7.3. Analysis
Comparison 7: Trabeculotomy‐trabeculectomy versus Ahmed valve implantation, Outcome 3: Mean corneal diameter
7.4
7.4. Analysis
Comparison 7: Trabeculotomy‐trabeculectomy versus Ahmed valve implantation, Outcome 4: Mean axial length
7.5
7.5. Analysis
Comparison 7: Trabeculotomy‐trabeculectomy versus Ahmed valve implantation, Outcome 5: Mean number of glaucoma medications needed after surgery. We did not consider the use of glaucoma medications to maintain IOP as surgical failure if the IOP was ≤ 21 mmHg.
7.6
7.6. Analysis
Comparison 7: Trabeculotomy‐trabeculectomy versus Ahmed valve implantation, Outcome 6: Adverse outcomes
8.1
8.1. Analysis
Comparison 8: Trabeculotomy‐trabeculectomy plus mitomycin C versus trabeculectomy plus mitomycin C, Outcome 1: Mean IOP after surgery
8.2
8.2. Analysis
Comparison 8: Trabeculotomy‐trabeculectomy plus mitomycin C versus trabeculectomy plus mitomycin C, Outcome 2: Proportion with postoperative IOP ≤ 21 mmHg (surgical success) with or without glaucoma medications
8.3
8.3. Analysis
Comparison 8: Trabeculotomy‐trabeculectomy plus mitomycin C versus trabeculectomy plus mitomycin C, Outcome 3: Mean corneal diameter
9.1
9.1. Analysis
Comparison 9: 1 goniotomy versus 2 goniotomies, Outcome 1: Mean IOP after surgery
9.2
9.2. Analysis
Comparison 9: 1 goniotomy versus 2 goniotomies, Outcome 2: Surgical success
See this image and copyright information in PMC

Update of

References

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Abdelrahman 2018 {published data only}
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Colev 1977 {published data only}
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NCT01494974 {unpublished data only}
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Ozcan 2004 {published data only}
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Tamcelik 2008 {published data only}
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Tamcelik 2010a {published data only}
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Tamcelik 2010b {published data only}
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References to ongoing studies

ChiCTRIOR4005588 {unpublished data only}
    1. ChiCTRIOR4005588. Comparison between trabeculotomy and trabeculectomy combined with trabeculotomy in the treatment of primary congenital infant glaucoma: a prospective, randomized, and controlled clinical trial. www.who.int/trialsearch/trial2.aspx? Trialid=chictr-ior-14005588 (first received 20 November 2014).
CTRI201405004603 {unpublished data only}
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CTRI201901016998 {unpublished data only}
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References to other published versions of this review

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