Skip to main content
OpenTrials
Completed

NCT Number: NCT07800637

Deep Sclerectomy With Scleral Bed Fenestration Versus Trabeculectomy in Medically Uncontrolled Primary Open Angle Glaucoma Patients

this study tries to find the efficacy of adding certain modifications to deep sclerectomy in primary open angle glaucoma patients who can no be controlled by medical therapy and if it can reach trabeculectomy efficacy or not

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Minia university

Minya, Minya Governorate, 61111, Egypt

About this study

Glaucoma is an optic neuropathy that is characterized by progressive structural and functional deterioration of the optic nerve (1) Glaucoma is the second leading cause of blindness worldwide, although it is the most common cause of irreversible vision loss in the whole world (2) In 2013, the number of people (aged 40-80 years) diagnosed with glaucoma worldwide was 64.3 million, increasing to 76.0 million in 2020 and expected to reach 111.8 million in 2040 (2) Primary open angle glaucoma is the commonest subtype of glaucoma. The number of persons diagnosed with POAG was estimated 52.68 million in 2020 and expected to be 79.76 million in 2040 (3).

In primary open angle glaucoma vision preservation remains the aim of treatment through correcting the only treatable risk factor in glaucoma which is the intraocular pressure. This can be achieved by different modalities including medical, laser or surgical methods (4)

In many cases medical and laser therapy can provide an effective IOP control, while surgery is still indicated when they fail to lower IOP sufficiently, or if the patient is not compliant to those methods of treatment (5).

Surgeries done for treatment of POAG are variable, including penetrating surgeries & non penetrating surgeries (6)

The example of penetrating surgeries is the trabeculectomy (both conventional or with modifications as application of mitomycin) &while examples of non-penetrating surgeries are multiple as deep sclerectomy, canaloplasty, gonioscopy-assisted transluminal trabeculotomy , goniotomy with kahook dual blade, or I stent implantation(7).

Trabeculectomy is a filtration procedure that reduces IOP by creating a connection between the anterior chamber & the subconjunctival space after excision of a part of the trabecular meshwork. Unfortunately, although it reduces IOP effectively it is associated with a higher incidence of complications as hypotony, lost anterior chamber or suprachoroidal effusion (8).

Therefore, non-penetrating glaucoma surgeries as deep sclerectomy have been developed to improve the safety of the conventional filtering procedures(9).

Deep sclerectomy prevents the sudden hypotony that occurs in penetrating surgeries by creating progressive filtration of aqueous humor without perforating the eye through the preservation of the thin trabeculo-Descemet membrane (5) Nevertheless, many authors think that deep sclerectomy is less effective than trabeculectomy for intraocular pressure reduction ,hence adding a new modification to deep sclerectomy is needed to increase its efficacy (10)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients above 40 years old.
  • Primary open angle glaucoma patients who are uncontrolled on maximally tolerated medical therapy.
  • لاPhakic (with clear lens or visually insignificant cataract) patients

Exclusion criteria

  • Patients with any other type of glaucoma except for primary open angle glaucoma.
  • Patients who received previous laser therapy for glaucoma as laser trabeculoplasty.
  • Patients with severe ocular surface diseases as ocular cicatricial pemphigoid and severe dry eye
  • Previous ocular surgeries.
  • Patients with significant cataract.

Treatment and study plan

deep sclerectomy with scleral bed fenestration

Procedure

creating fenestrations in the scleral bed

trabeculectomy

Procedure

standard trabeculectomy with mitomycin c application

Primary outcomes

  1. IOP

    Time frame: 6 months

    comparing the IOP in mmgh between the two groups after surgery

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.