Summary of findings 3. Summary of findings for amniotic membrane.
| Amniotic membrane implanted during trabeculectomy compared with trabeculectomy alone for people with glaucoma | ||||||
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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) | ⊕⊕⊝⊝ low1,2 | |
| 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 | |||
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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) | ⊕⊕⊝⊝ low1,3 | ‐ |
| Other complications reported by included studies | ||||||
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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) | ⊕⊕⊝⊝ low1,2 | ‐ |
|
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) | ⊕⊕⊝⊝ low1,2 | ‐ |
|
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 low1,2,3 | ‐ |
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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.