Figueroa 1994.
| Methods | Method of allocation: not reported. 1 eye of participants with bilateral drusen was assigned to treatment and the fellow eye to control Masking: not reported if participants and providers, but participants could not be masked since there was no sham procedure. VA examiners were masked Exclusions after randomisation: none reported Losses to follow‐up: since they reported on results at last examination (mean follow‐up 3 years), assessing the impact of loss to follow‐up was difficult Unusual study design: paired or bilateral study; authors also reported on a parallel case series of people with CNV in 1 eye who were all treated in the fellow eye |
|
| Participants | Country: Spain Number randomised: 30 participants (60 eyes) Age: 69 years (range: 62 to 74) Inclusion criteria: AMD with large confluent soft drusen involving the fovea Exclusion criteria: not specified |
|
| Interventions | Treatment: green argon laser; 0.1 mW, 0.1 seconds, 100‐μm spot; laser spot on drusen in the temporal fovea, or grid pattern if drusen > 300 μm Control: observation Duration: mean 3 years (range: 1.5 to 5) |
|
| Outcomes | Occurrence of CNV, reduction of drusen, VA | |
| Notes | Drusen resolution possible also for drusen located far from the laser application Supported in part by National Institutes of Health grant NEI EY12769 and 5 P30 EY 01583, the Vivian Simkins Lasko Research Fund, the Nina C. Mackall Trust, and an unrestricted grant from Research to Prevent Blindness, New York, NY COI declaration: not reported |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Development of CNV/geographic atrophy | Low risk | Unmasked study, but CNV occurrence was sufficiently objective as a diagnosis to be considered unbiased |
| Blinding (performance bias and detection bias) Measurement of vision | Low risk | Masked visual examiner |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | See Results, Appendix 8. Data at mean follow‐up were reported. Since 12/30 participants were followed for < 3 years, it was difficult to assess the impact of this type of reporting. However, in the updated version of this review, we considered missing data as no risk of bias in bilateral studies because a participant with paired treatment and control eyes is missed |
| Selective reporting (reporting bias) | Unclear risk | Development of CNV and atrophy, as well as loss of ≥ 3 lines of VA were well defined and relevant outcomes |
| Other bias | Unclear risk | Unclear |