Ren 1999.
| Methods |
Study design: parallel‐group RCT Country: US Number randomized: Total: 228 Per group: apraclonidine = 114; pilocarpine = 114 Exclusions after randomization: none reported Number analyzed: Total: 228 Per group: apraclonidine = 114; pilocarpine = 114 Unit of analysis (participants vs eyes): participant (1 eye per participant) Losses to follow‐up: none reported How was missing data handled?: N/A Reported power calculation: yes Unusual study design?: none |
|
| Participants |
Age (mean ± SD; years): apraclonidine = 68.4 ± 11.4, pilocarpine = 70.3 ± 10.1 Females: apraclonidine = 62%, pilocarpine = 56% Inclusion criteria: POAG with bilateral elevation (> 21 mmHg before therapy), characteristic glaucomatous optic nerve damage on stereoscopic biomicroscopy, and glaucomatous visual field defects on Humphrey automated field testing Exclusion criteria: secondary OAG and previous intraocular surgery Equivalence of baseline characteristics: no, pre‐ALT IOP was higher in the apraclonidine group |
|
| Interventions |
Intervention 1: 1 drop apraclonidine 1%, 15 min before 180° LTP Intervention 2: 1 drop pilocarpine 4%, 15 min before 180° LTP Length of follow‐up: Planned: 24 hours Actual: 24 hours |
|
| Outcomes |
Primary outcome: IOP Secondary outcome: incidence of IOP spike Adverse events reported: yes, "There was an apparent lack of serious or longlasting side effects after single instillation of either apraclonidine or pilocarpine." Intervals at which outcomes assessed: 5 min; 1, 24 hours |
|
| Notes |
Trial registration: not reported Funding sources: "Supported in part by an unrestricted grant from Research to Prevent Blindness, Inc" Disclosures of interest: none reported Study period: not reported Reported subgroup analyses: yes, by regular medication type |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Study was an RCT but no description of how the randomization sequence was generated |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
| Masking of participants and personnel (performance bias) | Unclear risk | No information on masking of participants and personnel reported |
| Masking of outcome assessment (detection bias) | Unclear risk | No information on efforts to mask the outcome assessors reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear whether there were any missing data or how they were handled |
| Selective reporting (reporting bias) | Unclear risk | Unclear whether there was selective outcome reporting |
| Other bias | Low risk | None |