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

NCT07800637 | Completed DMC

• 1 other identifier: different glaucoma surgeries
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

deep sclerectomy with scleral bed fenestration; trabeculectomy; phakic

Outcome Measures

Primary Outcomes (1)

• IOP

  comparing the IOP in mmgh between the two groups after surgery

  6 months

Study Arms (2)

deep sclerectomy with scleral bed fenestration

ACTIVE COMPARATOR

19 eyes of primary open angle glaucoma patients had undergone deep sclerectomy with scleral bed fenestration

Procedure: deep sclerectomy with scleral bed fenestration; Procedure: Trabeculectomy

trabeculectomy

ACTIVE COMPARATOR

19 eyes of primary open angle glaucoma patients had undergone trabeculectomy surgery

Procedure: deep sclerectomy with scleral bed fenestration; Procedure: Trabeculectomy

Interventions

deep sclerectomy with scleral bed fenestration PROCEDURE

creating fenestrations in the scleral bed

deep sclerectomy with scleral bed fenestration; trabeculectomy

Trabeculectomy PROCEDURE

standard trabeculectomy with mitomycin c application

deep sclerectomy with scleral bed fenestration; trabeculectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of medicine, Minia university

Minya, Minya Governorate, 61111, Egypt

Location

Related Publications (8)

• Dada T, Sharma A, Midha N, Angmo D, Gupta S, Sihota R. Efficacy of Trabeculectomy Combined With Limited Deep Sclerectomy Versus Trabeculectomy Alone: A Randomized-controlled Trial. J Glaucoma. 2021 Dec 1;30(12):1065-1073. doi: 10.1097/IJG.0000000000001896.

  PMID: 34086608 BACKGROUND

• Kalala A, Gillmann K, Mermoud A. Prospective evaluation of penetrating deep sclerectomy in advanced open-angle glaucoma: Filtration surgery adapted to resource scarcity in developing countries. J Fr Ophtalmol. 2020 Mar;43(3):228-236. doi: 10.1016/j.jfo.2019.07.024. Epub 2020 Jan 24.

  PMID: 31987680 BACKGROUND

• Oh LJ, Wong E, Lam J, Clement CI. Comparison of bleb morphology between trabeculectomy and deep sclerectomy using a clinical grading scale and anterior segment optical coherence tomography. Clin Exp Ophthalmol. 2017 Sep;45(7):701-707. doi: 10.1111/ceo.12953. Epub 2017 May 9.

  PMID: 28371125 BACKGROUND

• Correia Barbosa R, Goncalves R, Bastos R, Alves Pereira S, Basto R, Viana AR, Tenedorio P. Trabeculectomy Vs Non-penetrating Deep Sclerectomy for the Surgical Treatment of Open-Angle Glaucoma: A Long-Term Report of 201 Eyes. Clin Ophthalmol. 2023 Jun 6;17:1619-1627. doi: 10.2147/OPTH.S405837. eCollection 2023.

  PMID: 37304331 BACKGROUND

• Diaz-Barreda MD, Sanchez-Marin I, Boned-Murillo A, Perez-Navarro I, Martinez J, Pardina-Claver E, Perez D, Ascaso FJ, Ibanez J. Modification of Corneal Biomechanics and Intraocular Pressure Following Non-Penetrating Deep Sclerectomy. J Clin Med. 2022 Feb 24;11(5):1216. doi: 10.3390/jcm11051216.

  PMID: 35268307 BACKGROUND

• Pantalon A, Feraru C, Tarcoveanu F, Chiselita D. Success of Primary Trabeculectomy in Advanced Open Angle Glaucoma. Clin Ophthalmol. 2021 May 27;15:2219-2229. doi: 10.2147/OPTH.S308228. eCollection 2021.

  PMID: 34079219 BACKGROUND

• Zhang N, Wang J, Li Y, Jiang B. Prevalence of primary open angle glaucoma in the last 20 years: a meta-analysis and systematic review. Sci Rep. 2021 Jul 2;11(1):13762. doi: 10.1038/s41598-021-92971-w.

  PMID: 34215769 BACKGROUND

• Melik Parsadaniantz S, Reaux-le Goazigo A, Sapienza A, Habas C, Baudouin C. Glaucoma: A Degenerative Optic Neuropathy Related to Neuroinflammation? Cells. 2020 Feb 25;9(3):535. doi: 10.3390/cells9030535.

  PMID: 32106630 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• hosney ah zain, dectorate

  Minia University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deep sclerectomy with scleral bed fenestration versus trabeculectomy in medically uncontrolled primary open angle glaucoma patients

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: September 2, 2026
• Study Start: February 20, 2025
• Primary Completion: April 20, 2026
• Study Completion: August 20, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)