Summary of findings for the main comparison. Vitrectomy compared to observation for idiopathic macular hole.
| Vitrectomy compared to observation for idiopathic macular hole | ||||||
| Patient or population: participants with idiopathic macular hole Settings: Intervention: vitrectomy Comparison: observation | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Observation | Vitrectomy | |||||
| Mean visual acuity (logMAR) at 6‐12 months Follow‐up: 6‐12 months | The mean visual acuity (logMAR) at 6‐12 months in the control groups was 0.6 to 0.9 logMAR | The mean visual acuity (logMAR) at 6‐12 months in the intervention groups was ‐0.16 logMAR better (‐0.23 to ‐0.09) | ‐ | 270 eyes (3 studies) | ⊕⊕⊕⊝ moderate1 | ‐ |
| Hole closure at 6‐12 months Follow‐up: 6‐12 months | 110 per 1000 | 796 per 1000 (649 to 891) | OR 31.4 (14.9 to 66.3) | 265 (3 studies) | ⊕⊕⊕⊕ high2 | ‐ |
| Reading acuity at 6 months | The mean reading acuity at 6 months in the control groups was 0.8 to 1.0 logMAR | The mean reading acuity at 6 months in the intervention groups was ‐0.17 better (‐0.26 to ‐0.07 better) | ‐ | 154 (2 studies) | ⊕⊕⊝⊝ low1,3 | ‐ |
| Reading speed (word/minute) at 6 months | The mean reading speed (word/minute) at 6 months in the control groups was 36 words/minute | The mean reading speed (word/minute) at 6 months in the intervention groups was 5.6 lower (14.42 lower to 3.22 higher) | ‐ | 118 (1 study) | ⊕⊕⊝⊝ low1,3 | ‐ |
| Hole recurrence | Data on macular hole recurrence after initially successful surgery could not be extracted from the studies. | |||||
| Adverse outcomes |
Retinal detachment:Freeman 1997 reported no cases; Ezra 2004 described the retinal detachment rate for the vitrectomy groups only (vitrectomy alone or with serum), with values of 7/124 (5.6%), most detachments occurring in the first 6 weeks. Symptomatic visual field defects (Ezra 2004) in the inferotemporal sector were found in 4/124 eyes (3.2%), with 15 eyes (12.1%) having asymptomatic defects. Re‐operation (Ezra 2004): 18 (14.5%) of the surgical eyes, with subsequent hole closure in 78% of cases. |
|||||
| Costs | Cost data were not available in the included studies. | |||||
| *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). CI: confidence interval; OR: odds 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. | ||||||
1 No or unclear masking of participant, physician, or outcome assessor (‐1)
2 No downgrade, as a result of no or unclear masking of outcome assessor in one study (‐1), but upgraded because of strong effect (+1) 3 Wide confidence interval (‐1)