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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07800637
Enrollment
39
Registered
2026-09-02
Start date
2025-02-20
Completion date
2026-08-20
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Sclerectomy, Open Angle Glaucoma (OAG), Open Angle Glaucoma (OAG) Surgeries

Keywords

deep sclerectomy with scleral bed fenestration, trabeculectomy, phakic

Brief summary

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

Detailed description

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)

Interventions

PROCEDUREdeep sclerectomy with scleral bed fenestration

creating fenestrations in the scleral bed

PROCEDURETrabeculectomy

standard trabeculectomy with mitomycin c application

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients above 40 years old. 2. Primary open angle glaucoma patients who are uncontrolled on maximally tolerated medical therapy. 3. لاPhakic (with clear lens or visually insignificant cataract) patients

Exclusion criteria

1. Patients with any other type of glaucoma except for primary open angle glaucoma. 2. Patients who received previous laser therapy for glaucoma as laser trabeculoplasty. 3. Patients with severe ocular surface diseases as ocular cicatricial pemphigoid and severe dry eye 4. Previous ocular surgeries. 5. Patients with significant cataract.

Design outcomes

Primary

MeasureTime frameDescription
IOP6 monthscomparing the IOP in mmgh between the two groups after surgery

Countries

Egypt

Contacts

STUDY_DIRECTORhosney ah zain, dectorate

Minia University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026