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Deep Sclerectomy With Trabeculotomy in Advanced GlaucomaNCT07895537

Short-Term Efficacy and Safety of Combined Deep Sclerectomy With Trabeculotomy in Advanced Glaucoma: A Prospective Interventional Study

A study testing Combined Deep Sclerectomy with Trabeculotomy in people with Deep Sclerectomy With Trabeculotomy in Advanced Glaucoma, run by Minia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Combined Deep Sclerectomy with Trabeculotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteEgypt
Study dates
15 Sep 2025to 5 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Al azhar university

    Minya, 61511

Other trials in Egypt

About this study

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.

Read more

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.

Read the detailed description

Detailed Description

Glaucoma is a chronic, progressive optic neuropathy characterized by structural damage to the optic nerve and corresponding visual field loss. In patients with advanced glaucoma, achieving adequate intraocular pressure (IOP) control is particularly important because further disease progression may result in substantial and irreversible visual impairment. When medical and/or laser therapy fails to achieve the individualized target IOP, surgical intervention may be required.

Deep sclerectomy is a non-penetrating glaucoma filtration procedure intended to improve aqueous humor outflow while avoiding deliberate full-thickness entry into the anterior chamber. Trabeculotomy enhances aqueous drainage by opening the trabecular meshwork and improving access to Schlemm's canal. Combining these procedures may provide complementary mechanisms for lowering IOP.

The present prospective, single-center interventional study will evaluate the short-term efficacy and safety of a modified surgical technique combining deep sclerectomy, trabeculotomy in patients with advanced glaucoma who require surgical IOP reduction.

The study will recruit 20 eyes of eligible adult patients with advanced glaucoma at the Department of Ophthalmology, Faculty of Medicine, Al-Azhar University. Participants will undergo a standardized preoperative ophthalmic assessment, including visual acuity measurement, Goldmann applanation tonometry, slit-lamp examination, gonioscopy, optic nerve assessment, and visual field testing when feasible.

All procedures will be performed by the same experienced glaucoma surgeon using a standardized surgical technique. The procedure will include creation of a superficial scleral flap, deep scleral dissection with exposure of the trabeculo-Descemet membrane, trabeculotomy, and placement of a sub-flap mattress suture designed to maintain controlled separation between the superficial scleral flap and the underlying scleral bed. The intended purpose of this modification is to regulate the intrascleral space while allowing continued aqueous percolation. The conjunctiva will be closed watertight.

Postoperative management will follow a standardized regimen consisting of topical antibiotic treatment, topical corticosteroids with tapering according to clinical findings, and lubricants as required. Antiglaucoma medications and additional interventions will be used when clinically indicated according to the treating surgeon's assessment and the study protocol.

Participants will be followed on postoperative day 1, at week 1, and at months 1, 3, and 6. Assessments will include IOP, best-corrected visual acuity, slit-lamp findings, anterior chamber status, filtering bleb appearance, antiglaucoma medication requirements, and postoperative complications. Additional glaucoma medication, laser treatment, or surgery will be documented when required.

The primary outcome is the change in IOP from baseline to three months after surgery. Secondary outcomes include percentage IOP reduction, change in the number of antiglaucoma medications, complete and qualified surgical success, change in visual acuity, time to surgical failure, need for additional intervention, and the frequency and severity of intraoperative and postoperative complications.

Continuous variables will be summarized according to their distributions. Paired Student's t-tests or Wilcoxon signed-rank tests will be used, as appropriate, to compare preoperative and postoperative measurements. Categorical variables will be summarized as frequencies and percentages.

The study is intended to provide preliminary evidence regarding the short-term efficacy and safety of this modified surgical technique. Because it is a single-center interventional study with a planned sample of 20 eyes and no comparison group, the findings will be interpreted cautiously and will not establish superiority over other glaucoma procedures.

Being tested
Combined Deep Sclerectomy with Trabeculotomy
Keywords
Advanced glaucoma; Deep sclerectomy; Trabeculotomy; Intraocular pressure; Glaucoma surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Deep Sclerectomy with TrabeculotomyProcedure or surgery

    Participants with advanced glaucoma requiring surgical intraocular pressure reduction will undergo combined deep sclerectomy and trabeculotomy . The procedure involves creation of superficial and deep scleral flaps, removal of deep scleral tissue to expose the trabeculo-Descemet membrane, trabeculotomy to enhance aqueous outflow, and placement of a sub-flap mattress suture to maintain controlled separation between the superficial scleral flap and the underlying scleral bed. The conjunctiva will be closed watertight. All participants will receive standardized postoperative treatment and follow-up examinations for six months. The intervention will be evaluated for its effect on intraocular pressure, antiglaucoma medication requirements, visual acuity, surgical success, and postoperative complications.

Study groups in NCT07895537
Study groupRoleWhat they receive
Combined Deep Sclerectomy with Trabeculotomy and Sub-Flap Mattress SutureExperimentalParticipants with advanced glaucoma requiring surgical intraocular pressure reduction will undergo combined deep sclerectomy and trabeculotomy . The procedure is intended to reduce intraocular pressure by enhancing aqueous humor outflow while maintaining controlled separation of the superficial scleral flap from the underlying scleral bed. All participants will receive standardized postoperative treatment and follow-up for six months to assess intraocular pressure, antiglaucoma medication requirements, visual acuity, surgical success, and postoperative complications
Receives: Procedure: Combined Deep Sclerectomy with Trabeculotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Intraocular Pressure from Baseline to 3 Months After Surger

    he change in intraocular pressure (IOP), measured in mmHg using Goldmann applanation tonometry, from the preoperative baseline measurement to 3 months after combined deep sclerectomy with trabeculotomy and sub-flap mattress suture. The change will be calculated as the 3-month postoperative IOP minus the baseline IOP.

    Measured: Baseline (preoperative) to 3 months after surger

Secondary outcomes (4)
  1. Change in Antiglaucoma Medication Requirements

    Change in the number of antiglaucoma medications used by participants from the preoperative baseline to postoperative follow-up visits.

    Measured: Baseline to 1, 3, and 6 months after surgery.

  2. Percentage Reduction in Intraocular Pressure

    Percentage reduction in intraocular pressure (IOP) from baseline, calculated as [(baseline IOP - postoperative IOP) / baseline IOP] × 100.

    Measured: Baseline to 1, 3, and 6 months after surgery..

  3. Percentage Reduction in Intraocular Pressure

    Percentage reduction in intraocular pressure (IOP) from baseline, calculated as [(baseline IOP - postoperative IOP) / baseline IOP] × 100.

    Measured: Baseline to 1, 3, and 6 months after surgery.

  4. Proportion of Eyes Achieving Complete and Qualified Surgical Success

    The proportion of eyes meeting the predefined criteria for complete and qualified surgical success. Complete success is defined as IOP within the prespecified target range without antiglaucoma medications or additional glaucoma surgery. Qualified success is defined as IOP within the prespecified target range with or without antiglaucoma medications and without additional glaucoma surgery.

    Measured: 3 and 6 months after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start15 Sep 2025
  3. Primary completion5 Mar 2026
  4. Study completion5 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895537
Sponsor's protocol ID
OPH026/10/247/9/2025
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly shared because of patient confidentiality and privacy considerations. The study results will be disseminated in aggregate form. Requests for access to anonymized data may be considered by the principal investigator, subject to institutional policies, ethical approval, and applicable data protection requirements.

Publications

  • Kotb MS, El Gharbawy SA, Abdelrahman AM, Makled HS. Sutureless versus conventional deep sclerectomy for management of open angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2023 Apr;261(4):1083-1090. doi: 10.1007/s00417-022-05910-4. Epub 2022 Nov 26.

    PubMed 36435917
  • Sharifipour F, Yazdani S, Asadi M, Saki A, Nouri-Mahdavi K. Modified Deep Sclerectomy for the Surgical Treatment of Glaucoma. J Ophthalmic Vis Res. 2019 Apr-Jun;14(2):144-150. doi: 10.4103/jovr.jovr_228_17.

    PubMed 31114650
  • Luke C, Dietlein TS, Luke M, Konen W, Krieglstein GK. A prospective trial of phaco-trabeculotomy combined with deep sclerectomy versus phaco-trabeculectomy. Graefes Arch Clin Exp Ophthalmol. 2008 Aug;246(8):1163-8. doi: 10.1007/s00417-008-0821-8. Epub 2008 Apr 15.

    PubMed 18414886

Questions about this trial

What is this clinical trial studying?

A study testing Combined Deep Sclerectomy with Trabeculotomy in people with Deep Sclerectomy With Trabeculotomy in Advanced Glaucoma, run by Minia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Intraocular Pressure from Baseline to 3 Months After Surger (time frame: Baseline (preoperative) to 3 months after surger). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07895537, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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