NCT04673201Completed
Management Pediatric Steroid Induced Glaucoma
Ab Externo Circumferential Suture Trabeculotomy Versus Non-Penetrating Deep Sclerectomy for Pediatric Steroid-Induced Ocular Hypertension and Glaucoma: A 2-Year Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
Purpose: To compare the efficacy and safety of ab externo circumferential suture trabeculotomy (ACST) and non-penetrating deep sclerectomy (NPDS) in children with steroid-induced ocular hypertension or glaucoma over 24 months. Methods: In this prospective, randomized, controlled trial conducted at the Mansoura Ophthalmic Center, 54 children aged 7 to 17 years with steroid-induced intraocular pressure (IOP) elevation uncontrolled despite steroid withdrawal and maximal tolerated medical therapy were randomized 1:1 to ACST (n = 27) or NPDS (n = 27); one eye per child was analyzed. The primary outcome was mean IOP at 24 months. Secondary outcomes were anti-glaucoma medication use, complete and qualified success (IOP ≤18 mmHg without and with medication), best-corrected visual acuity (BCVA), visual-field mean deviation, complications, and additional interventions. Keywords: Steroid induced glaucoma, trabeculectomy, trabeculotomy .
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 12 Dec 2020
- Start date
- 20 Nov 2020
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Mansoura University
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT04673201
What you commit to
- Study type: Interventional
- Participants enrolled: 54
- From 20 Nov 2020 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (1) history of previous glaucoma surgery; (2) other forms of glaucoma unrelated to steroid use; (3) congenital glaucoma; and (4) complicated cataract or other significant ocular comorbidity.
Who the study is looking for
- (1) age 7 to 17 years; (2) elevated intraocular pressure (IOP ≥ 22 mmHg) secondary to corticosteroid use that persisted after discontinuation of steroids and maximal tolerated medical therapy; (3) ability to comply with the study follow-up schedule; and (4) written informed consent from a parent or legal guardian and assent from the child when appropriate.
- Steroid-induced ocular hypertension was defined as IOP ≥ 22 mmHg after corticosteroid exposure without optic-nerve or visual-field damage. Steroid-induced glaucoma was defined as elevated IOP with glaucomatous optic-disc changes (cup-to-disc ratio ≥ 0.6 or asymmetry ≥ 0.2) and/or a corresponding visual-field defect on standard automated perimetry, in the absence of other identifiable causes of glaucoma.
Age in the registry: 2 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mansoura university ophthalmic center Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.