El Sayyad 2000.
Methods |
Unit of analysis: paired (1 eye per participant had DS, the other had trabeculectomy) Method of allocation: not stated Masking (outcome assessment): not stated Exclusions after randomisation: 2 participants were excluded and replaced due to conversion from DS to trabeculectomy. Losses to follow‐up: none Compliance: not stated Study design (intention‐to‐treat or available case analysis): 39 participants (78 eyes) with bilateral POAG underwent bilateral filtering surgery between October 1997 and March 1998. Participants were assigned randomly to receive DS in 1 eye and trabeculectomy in the other; the surgeries were scheduled with no more than 3 days between them. Participants were followed up to 12 months after surgery. |
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Participants |
Country of enrolment: Saudi Arabia Number randomised: 39 participants (78 eyes) Age: 53.4 ± 9.6 years (range: 38 to 75 years) Sex: men (62.5%) Ethnicity: not stated Main inclusion criteria: patients with uncontrolled glaucoma despite maximally tolerated medications Main exclusion criteria: patients with previous ocular surgery, patients younger than 35 years of age, or those with significant posterior segment eye disorders |
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Interventions |
Type of surgical method: DS in 1 eye and trabeculectomy in the other Use of adjuvants: ‐5FU: 17 eyes (43.6%) in deep sclerectomy group 15 eyes (38.5%) in trabeculectomy group ‐Goniopuncture: 4 eyes (10.3%) in deep sclerectomy group ‐Argon Suture lysis: 17 eyes(43.6%) in trabeculectomy group Any immediate (within 2 weeks) postoperative interventions: Resuturing of the conjunctival flap was required in 1 case with leak 3 days postoperatively in the trabeculectomy group. Argon laser suture lysis was performed in the early postoperative period in 17 eyes (43.6%) in the trabeculectomy group. |
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Outcomes |
IOP total success (final IOP ≤21 mmHg without anti‐glaucoma medications):
DS group: 31 eyes (79%)
Trabeculectomy group: 33 eyes (85%) IOP qualified success (final IOP ≤ 21 mmHg with anti‐glaucoma medications): DS group: 36 eyes (92.3%) Trabeculectomy group: 37 eyes (94.7%) IOP failure: DS group: 3 eyes (7.7%) Trabeculectomy group: 2 eyes (5.1%) Field of vision: not stated Optic disc: not stated Drop in visual acuity 2 lines or more: 2 eyes in the DS group and 1 eye in the trabeculectomy group showed a drop in visual acuity of 2 Snellen lines or more because of age‐related maculopathy After trabeculectomy 1 eye developed progressive cataract with the loss of 3 Snellen lines Drop in postoperative medication score: the mean number of anti‐glaucoma medications at 12 months was 0.3 ± 0.4 in the sclerectomy group and 0.27 ± 0.50 in the trabeculectomy group. This is compared to preoperative 2.4 ± 0.7 in the sclerectomy group and 2.6 ± 0.6 in the trabeculectomy group. Adverse effects: DS group: 1 case (2.6%) had conjunctival leak, 1 case (2.6%) had hyphaema and 1 case (5.1%) had iris incarceration No cases of hypotony, progressive cataract or shallow AC were reported in this group Trabeculectomy group: 1 case (2.6%) had hypotony, 3 cases (7.7%) had conjunctival leak, 3 cases (7.7%) had hyphaema, 3 cases (7.7%) had flat AC, 2 cases (5.1%) had postoperative inflammation and 1 case (2.6%) had cataract Length of follow‐up: 12 months Exclusions and drop outs: 2 patients were excluded. No drop outs. |
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Notes | The trial investigators did not consider successful cases of 5‐FU and goniopuncture as qualified success | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The authors say participants were assigned randomly but no definite method of randomisation was stated in the study |
Allocation concealment (selection bias) | Unclear risk | No information about allocation concealment was given in the study |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | It is unclear whether the persons assessing outcome were unaware of the nature of the procedure in each eye of the participant |
Incomplete outcome data (attrition bias) All outcomes | High risk | Follow‐up rates were equal in both groups ‐ however, 2 participants were excluded from the study (and replaced) because of perforation of Descemet's membrane occurring during deep sclerectomy |
Selective reporting (reporting bias) | Unclear risk | Insufficient evidence to judge as high or low |