Eter 2002.
| Methods | Multicentre: 3 centres. Allocation: central telephone; blocked by centre. Masking: participant: no; provider: no; outcome: no. Exclusions after randomisation: 3 treatment, 1 control. | |
| Participants | Country: Germany. Number randomised: 45. Median age: 74. Sex: 53% women. Inclusion criteria: age 45+ years; classic/occult CNV; informed consent; no prior radiation treatment to head; no vascular eye disease; no prior treatment of AMD. Exclusion criteria: | |
| Interventions | Treatment: 20 Gy (10 x 2 Gy). Control: observation. Duration: one week. | |
| Outcomes | Visual acuity (logarithmic chart). | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | "Forty‐five eyes of 45 patients [...] were assigned randomly in a ratio of 2:1 to either radiation treatment or observation." Page 14, patients and methods. |
| Allocation concealment? | Unclear risk | Not reported. |
| Blinding? Visual acuity | High risk | Not reported. As control group was observation only assumed visual acuity assessment not masked. |
| Blinding? Lesion size on fluorescein angiography | High risk | Not reported. As control group was observation only assumed CNV assessment not masked. |
| Incomplete outcome data addressed? All outcomes | High risk | "Although 45 patients were randomized to either treatment or follow‐up, 27 patients in the radiation group and 15 patients in the control group could be enrolled in the study. Three patients were lost to follow‐up because motivation for further examinations was low and because they needed to be accompanied by relatives due to their age and visual acuity." Page 14, patients and methods. However, no information given as to which group the excluded patients belonged. No information given as to numbers examined at six month follow‐up. |
| Free of selective reporting? | High risk | See additional table 3. |
| Free of other bias? | Low risk | |