Summary of findings 1. Summary of findings.
| Pars plana vitrectomy with internal limiting membrane flap versus pars plana vitrectomy with conventional internal limiting membrane peeling for large macular hole | |||||||
| Patient or population: people with large macular hole Setting: ophthalmology hospital or clinic Intervention: PPV with ILM flap Comparison: PPV with ILM peeling | |||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of eyes (studies) | Certainty of the evidence (GRADE) | Comments | ||
| Assumed risk (PPV with ILM peeling) | Corresponding risk (PPV with ILM flap) | ||||||
| Mean change in BCVA from baseline | No data were available for this outcome. | — | — | — | — | ||
| Mean postoperative BCVA (lower is better) | After 1 month | From 0.66 logMAR to 0.96 logMAR | The mean BCVA was on average 0.08 logMAR lower (95% CI −0.20 to 0.05) | — | 254 (4) | ⊕⊝⊝⊝ Very lowa,b,c | — |
| After ≥ 3 months | From 0.65 logMAR to 0.86 logMAR | The mean BCVA was on average 0.17 logMAR lower (95% CI −0.23 to ‐0.10) | — | 276 (4) | ⊕⊕⊝⊝ Lowa,b | Measurement time points were 3 months (Manasa 2018; Velez‐Montoya 2018), 6 months (Kannan 2018), and 12 months (Michalewska 2010). | |
|
Overall closure of macular hole at end of follow‐up |
858 per 1000 | 944 per 1000 (range 875 to 1000) |
RR 1.10 (95% CI 1.02 to 1.18) |
276 (4) | ⊕⊕⊕⊝ Moderateb | Measurement time points were 3 months (Manasa 2018; Velez‐Montoya 2018), 6 months (Kannan 2018), and 12 months (Michalewska 2010). | |
| Speed of visual acuity improvement | No data were available for this outcome. | — | — | — | — | ||
|
Type 1 macular hole closure at end of follow‐up |
589 per 1000 | 771 per 1000 (606 to 977) |
RR 1.31 (95% CI 1.03 to 1.66) |
276 (4) | ⊕⊕⊕⊝ Moderateb | Measurement time points were 3 months (Manasa 2018; Velez‐Montoya 2018), 6 months (Kannan 2018), and 12 months (Michalewska 2010). | |
|
Postoperative retinal detachment at end of follow‐up |
See comment | — | — | ⊕⊕⊝⊝ Lowd | Velez‐Montoya 2018 reported no retinal detachment in either surgery group. | ||
| *The risk in the intervention group (and its 95% CI) 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; ILM: internal limiting membrane; logMAR: logarithm of the minimum angle of resolution; MD: mean difference; OCT: optical coherence tomography; PPV: pars plana vitrectomy; RR: risk ratio. | |||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | |||||||
aDowngraded one level for indirectness (various time points pooled in the analysis). bDowngraded one level for risk of bias concerns. cDowngraded one level for imprecision (wide CI). dDowngraded two levels for imprecision (no events).