Helmy 2016.
| Study characteristics | ||
| Methods |
Study design: RCT, parallel‐group design with 1 study eye per child Number randomized (total and per group): 66 eyes of 66 children; 33 in each group Number analyzed (total and per group): 66 eyes of 66 children; 33 in each group Losses to follow‐up: not reported Length of follow‐up: Planned: 4 years (48 months) Actual: 4 years Sample size calculation (Y/N): N |
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| Participants |
Country: Egypt Age: combined trabeculotomy‐trabeculectomy: 13.5 ± 3.9 months; Ahmed valve implantation: 15.3 ± 5.8 months Gender: combined trabeculotomy‐trabeculectomy: 16/33 (48.5%) boys and 17/33 (51.5%) girls; Ahmed valve implantation: 17/33 (51.5%) boys and 16/33 (48.5%) girls Inclusion criteria: refractory primary congenital glaucoma who underwent previous incisional angle surgery (trabeculotomy and goniotomy) and have uncontrolled IOP Exclusion criteria: patients with other types of primary and secondary pediatric glaucomas and previous ocular surgery except incisional glaucoma surgery (trabeculotomy or trabeculectomy) Equivalence of baseline characteristics: P value not reported |
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| Interventions |
Intervention 1: combined trabeculotomy‐trabeculectomy The incision was done at the junction between the white and bluish transitional zone of the sclera, which coincides with the site of Shlemm’s canal. Then, Shlemm’s canal was entered. Successful entry into the canal was evidenced by gush of an aqueous liquid and/or blood. Then, trabeculotomy was performed using the internal arm of Harm's trabeclotome probe, first to the left then to the right to perform an incision along 100 to 120 degrees of circumference.The pre‐marked 2x2‐millimeter inner block tissue comprising the trabecular meshwork and scleral spur was excised with Vannus scissors, and peripheral iridectomy was performed with a base of at least 2 mm. Intervention 2: Ahmed valve implantation The valve was primed with balanced salt saline. The plate was fixed to the sclera with two 8/0 black nylon sutures. A 4‐millimeter radial scleral tunnel was created with a 23‐gauge needle toward the limbus. An anterior chamber paracentesis wound was created at the peripheral cornea, and 1% sodium hyaluronate was injected to prevent collapse of the anterior chamber after sclerotomy was done. The tube was shortened to the desired length with its sharp bevel facing anteriorly to allow 2 to 3 mm of tube in the anterior chamber. The tube of the implant entered the anterior chamber parallel to the iris plane through the radial sclerotomy track. The tube was fixed to the sclera with 9/0 black nylon suture. |
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| Outcomes |
Outcomes:
Intervals at which outcome assessed: 1, 3, and 6 months and every 6 months thereafter up to 48 months Issues with outcome assessment: none Adverse effects: yes |
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| Notes |
Type of study: published Funding: not reported Declaration of interest: "There is no conflict of interest to be declared." Study period: 2011 to 2012 Clinical trial registry: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation was not reported: "The patients were randomized into two groups, each with 33 patients" |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not described. |
| Masking of participants and personnel (performance bias) | Unclear risk | Masking of participants and personnel was not reported. |
| Masking of outcome assessment (detection bias) | Unclear risk | Masking of outcome assessors was not reported. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers of participants who were excluded or lost to follow‐up were not reported. |
| Selective reporting (reporting bias) | Unclear risk | Neither protocol nor clinical trial registry was found. |
| Other bias | Unclear risk | Source of funding was not reported. |