Duan 2003.
| Methods |
Study design: parallel group, randomized controlled trial Number randomized: 159 eyes of 154 participants Exclusions after randomization: 43 eyes of 38 participants at 12 months Number analyzed: 116 eyes of 116 participants at 12 months Unit of analysis: eyes Handling of missing data: participants lost to follow‐up were excluded from the analysis Sample size calculation: not reported |
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| Participants |
Country: China Mean age: 50 years Gender: 85 (55%) men and 69 (45%) women Inclusion criteria: refractory glaucoma (IOP > 25 mmHg on combined pharmacologic therapy) Exclusion criteria: none reported Equivalence of baseline characteristics: mean IOP at baseline was similar in both intervention groups; the without MMC group had almost twice as many participants with aphakia as in the MMC group; no information on other baseline characteristics was reported Diagnoses in participants: neovascular glaucoma; uveitic glaucoma; traumatic glaucoma, primary angle‐closure glaucoma; secondary angle‐closure glaucoma; juvenile glaucoma; aphakic glaucoma |
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| Interventions |
MMC group (n = 65): Hunan aqueous device with adjunctive topical application of 0.4 mg/mL MMC with a sponge, applied to the sclera near the equator for 1 to 5 minutes followed by rinsing of extra MMC with balanced salt solution (duration of MMC was determined as follows: minimum duration was 1 minute with addition of 1 minute with each of the following characteristics: age of patient less than 40 years; thick connective tissue; rubeosis iris; IOP > 40 mmHg after combined drug therapy) No MMC group (n = 94): Hunan aqueous device with no MMC |
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| Outcomes |
Outcomes (primary and secondary outcomes not differentiated): mean IOP; surgical success, defined as IOP between 6 and 21 mmHg; best‐corrected visual acuity Length of follow‐up: every 3 months for the first postoperative year and every 6 months thereafter |
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| Notes |
Study period: July 1995 to July 2001 Trial registration: not reported Funding and conflicts of interest: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not reported |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
| Masking of participants and personnel (performance bias) | Unclear risk | Masking of participants and personnel not reported |
| Masking of outcome assessment (detection bias) | Unclear risk | Masking of outcome assessors not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 38/154 (25%) participants did not complete one year of follow‐up. |
| Selective reporting (reporting bias) | Unclear risk | No protocol or trial registry record available to compare outcomes |
| Other bias | Low risk | None identified |