NCT07895537Completed
Short-Term Efficacy and Safety of Combined Deep Sclerectomy With Trabeculotomy in Advanced Glaucoma: A Prospective Interventional Study
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
\*\*Brief Summary\*\* Glaucoma is a progressive eye disease that can lead to irreversible vision loss if intraocular pressure (IOP) is not adequately controlled. Some patients with advanced glaucoma require surgery when medications and/or laser treatment fail to achieve the desired pressure reduction. This prospective, single-center interventional study aims to evaluate the short-term effectiveness and safety of a combined glaucoma surgery involving deep sclerectomy, trabeculotomy. The study will include 20 eyes of eligible adult patients with advanced glaucoma who require surgical treatment to lower intraocular pressure. All participants will undergo the planned surgical procedure and receive postoperative care according to a standardized protocol. Follow-up examinations will be performed on the first postoperative day, at one week, and at one, three, and six months after surgery. The primary outcome will be the change in intraocular pressure from baseline to three months after surgery. Secondary outcomes will include changes in the number of glaucoma medications required, visual acuity, surgical success, the need for additional treatment, and the occurrence of intraoperative or postoperative complications. The findings are expected to provide information about the short-term effectiveness and safety of this modified surgical technique in patients with advanced glaucoma. As a single-center study without a comparison group, the results will be interpreted in the context of its design and sample size.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 19 Oct 2026
- Start date
- 15 Sept 2025
- Primary completion date
- 5 Mar 2026
- Lead sponsor
- Minia University
- Diseases
- Glaucoma
- NCT number
- NCT07895537
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 15 Sept 2025 to the primary completion date, 5 Mar 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \*\*Inclusion Criteria\*\*
- Age 18 years or older.
- Established diagnosis of glaucoma requiring surgical intraocular pressure reduction.
- Advanced glaucomatous optic neuropathy, defined by structural and/or functional criteria, preferably including reliable visual field testing demonstrating advanced loss according to the Hodapp-Parrish-Anderson classification when feasible.
- Intraocular pressure above the individualized target despite maximally tolerated topical antiglaucoma therapy and/or previous laser treatment, or documented glaucoma progression despite apparently controlled intraocular pressure.
- Open or sufficiently accessible anterior chamber angle anatomy suitable for the planned trabeculotomy.
- Ability to understand the study procedures and provide written informed consent.
- Willingness and ability to attend all scheduled postoperative follow-up visits.
- \*\*Exclusion Criteria\*\*
- Previous glaucoma filtering surgery in the study eye that substantially alters the intended surgical site.
- Active ocular inflammation or uncontrolled uveitis.
- Active infectious ocular disease.
- Significant corneal opacity preventing adequate surgical visualization or reliable intraocular pressure measurement.
- Severe ocular surface disease interfering with postoperative assessment.
- Previous major conjunctival surgery in the planned filtration area.
- Neovascular glaucoma requiring a different surgical strategy.
- Uncontrolled active retinal disease requiring urgent vitreoretinal intervention.
- Severe ocular trauma or extensive conjunctival scarring.
- Inability to provide informed consent or comply with the follow-up schedule.
- Any systemic or ocular condition judged by the investigator to make participation inappropriate or unsafe.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al azhar university Coordinator of this site? Confirm its status | Minya | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.