Slow-coagulation trans-scleral cyclophotocoagulation versus trabeculectomy with mitomycin C for uncontrolled open-angle glaucoma after cataract surgery
Slow Coagulation Trans-Scleral Cyclophotocoagulation Versus Trabeculectomy in Medically Uncontrolled Open-Angle Glaucoma in Pseudophakic Patients
This trial will test whether slow-coagulation trans-scleral cyclophotocoagulation or trabeculectomy with mitomycin C better lowers eye pressure in people over 40 with pseudophakic open-angle glaucoma not controlled by medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya) |
| Trial ID | NCT07152132 on ClinicalTrials.gov |
What this trial studies
This interventional comparison enrolls pseudophakic patients with open-angle glaucoma whose intraocular pressure remains high despite medical therapy. Participants receive either slow-coagulation trans-scleral cyclophotocoagulation (SC-TSCPC) or trabeculectomy with mitomycin C and are followed for post-procedure intraocular pressure, need for glaucoma medications, visual field status, and complications. The trial focuses on patients with moderate visual field loss and defects outside the central 5 degrees. Outcomes will inform relative effectiveness and safety profiles of a laser cyclodestructive approach versus a traditional filtration surgery in this patient group.
Who should consider this trial
Good fit: Ideal candidates are people older than 40 who have open-angle glaucoma after uncomplicated cataract surgery with an intraocular lens and whose pressure is not controlled on two glaucoma medications or who cannot tolerate medications.
Not a fit: Patients with prior glaucoma surgery, aphakia, active uveitis, significant media opacity, recent topical steroid use, severe ocular surface disease, or other excluded ocular interventions are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, the trial could identify a less invasive option that lowers eye pressure with fewer serious complications for pseudophakic patients who fail medical therapy.
How similar studies have performed: Trabeculectomy with MMC is an established method for lowering intraocular pressure, and trans-scleral cyclophotocoagulation (including slower coagulation techniques) has shown benefit in refractory glaucoma, but direct comparisons in pseudophakic open-angle glaucoma are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patients above 40 years old. 2\. POAG who underwent previous uncomplicated cataract surgery with intraocular lens implantation. 3\. Pseudophakic patients with medically uncontrolled glaucoma in spite of the use of two anti-glaucoma medications or intolerance to medical therapy. 4\. Visual field defects in both the superior and inferior hemi-fields outside the central 5 degrees of fixation. 5\. Mean deviation on perimetry ranges between -6 dB and -12 dB Exclusion Criteria: * 1\. Patients with history of previous glaucoma surgery. 2. Patients who have used topical steroids within the last three months. 3. Patients with significant media opacity, such as corneal opacity, that obstructs fundoscopic examination. 4\. Patients with ocular diseases as uveitis. 5. Patients with severe ocular surface disorders as ocular cicatricial pemphigoid. 6\. Aphakic patients. 7. Ocular interventions apart from YAG posterior capsulotomy.
Where this trial is running
Minya
- Minia University Hospital — Minya, Egypt (Recruiting)
Study contacts
- Study coordinator: Hazem M Abdelaziz, Master
- Email: hazem.m.abdelaziz@mu.edu.eg
- Phone: 01010045499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.