Open Angle Glaucoma (OAG) SurgeriesNCT07800637
Deep Sclerectomy With Scleral Bed Fenestration Versus Trabeculectomy in Medically Uncontrolled Primary Open Angle Glaucoma Patients
A study testing deep sclerectomy with scleral bed fenestration and Trabeculectomy in people with Open Angle Glaucoma (OAG) Surgeries and Deep Sclerectomy, run by Minia University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma (OAG) Surgeries, Deep Sclerectomy, Open Angle Glaucoma (OAG)
- What is being tested?
- deep sclerectomy with scleral bed fenestration and Trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 20 Aug 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine, Minia university
Minya, Minya Governorate, 61111
About this study
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
Read the 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)
- Being tested
- deep sclerectomy with scleral bed fenestration, Trabeculectomy
- Keywords
- deep sclerectomy with scleral bed fenestration, trabeculectomy, phakic
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep sclerectomy with scleral bed fenestrationProcedure or surgery
creating fenestrations in the scleral bed
TrabeculectomyProcedure or surgery
standard trabeculectomy with mitomycin c application
| Study group | Role | What they receive |
|---|---|---|
| deep sclerectomy with scleral bed fenestration | Active comparator | 19 eyes of primary open angle glaucoma patients had undergone deep sclerectomy with scleral bed fenestration Receives: Procedure: deep sclerectomy with scleral bed fenestration; Procedure: Trabeculectomy |
| trabeculectomy | Active comparator | 19 eyes of primary open angle glaucoma patients had undergone trabeculectomy surgery Receives: Procedure: deep sclerectomy with scleral bed fenestration; Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
comparing the IOP in mmgh between the two groups after surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start20 Feb 2025
- Primary completion20 Apr 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Open Angle Glaucoma (OAG) SurgeriesStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nosaiba Essam Ahmed, Minia University
- Investigators
- hosney ah zain, dectorate, Study director, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800637
- Sponsor's protocol ID
- different glaucoma surgeries
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34086608Kalala 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.
PubMed 31987680Oh 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.
PubMed 28371125Correia 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.
PubMed 37304331Diaz-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.
PubMed 35268307Pantalon 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.
PubMed 34079219Zhang 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.
PubMed 34215769Melik 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.
PubMed 32106630
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Sclerectomy With Scleral Bed Fenestration Versus Trabeculectomy in Medically Uncontrolled Primary Open Angle Glaucoma Patients
- ClinicalTrials.gov ID
- NCT07800637
- Acronym / sponsor ID
- different glaucoma surgeries
- Keywords
- deep sclerectomy with scleral bed fenestration, trabeculectomy, phakic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep sclerectomy with scleral bed fenestration | Active comparator | Procedure: deep sclerectomy with scleral bed fenestration, Procedure: Trabeculectomy19 eyes of primary open angle glaucoma patients had undergone deep sclerectomy with scleral bed fenestration |
| trabeculectomy | Active comparator | Procedure: deep sclerectomy with scleral bed fenestration, Procedure: Trabeculectomy19 eyes of primary open angle glaucoma patients had undergone trabeculectomy surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep sclerectomy with scleral bed fenestrationcreating fenestrations in the scleral bed | Procedure or surgery | deep sclerectomy with scleral bed fenestration, trabeculectomy |
| Trabeculectomystandard trabeculectomy with mitomycin c application | Procedure or surgery | deep sclerectomy with scleral bed fenestration, trabeculectomy |
Primary outcome
IOP
Time frame: 6 months
comparing the IOP in mmgh between the two groups after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 34086608Dada 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.
- Background: PubMed 31987680Kalala 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.
- Background: PubMed 28371125Oh 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.
- Background: PubMed 37304331Correia 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.
- Background: PubMed 35268307Diaz-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.
- Background: PubMed 34079219Pantalon 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.
- Background: PubMed 34215769Zhang 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.
- Background: PubMed 32106630Melik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hosney ah zain, dectorate study director
Minia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep sclerectomy with scleral bed fenestration and Trabeculectomy in people with Open Angle Glaucoma (OAG) Surgeries and Deep Sclerectomy, 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 3 inclusion and 5 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 2 Sep 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?
IOP (time frame: 6 months). 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 NCT07800637, which also lists 8 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 2 Sep 2026.