Open Angle Glaucoma (OAG)NCT07425743
Conventional Non-Penetrating Deep Sclerectomy Versus Modified Subflap Mattress Suture in OAG
A study testing Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS) and Conventional Nonpenetrating Deep Sclerectomy (NPDS) in people with Open Angle Glaucoma (OAG), run by Beni-Suef University at 2 sites in Egypt.
Trial summary
The goal of this clinical trial is to learn if modified non-penetrating deep sclerectomy (NPDS) with a sub-flap mattress suture works to treat open-angle glaucoma (OAG). It will also learn about the safety and effectiveness of this modified surgical approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open Angle Glaucoma (OAG)
- What is being tested?
- Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS) and Conventional Nonpenetrating Deep Sclerectomy (NPDS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesEgypt
- Study dates
- 7 Nov 2022to 1 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with primary or secondary open-angle glaucoma (OAG), either uncontrolled or intolerant to medical therapy
Who cannot join
- Past glaucoma procedures, including laser therapy, lens extraction, previous refractive surgery, angle closure, and neovascular glaucoma.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Beni-Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62511
The Glaucoma Department at the Memorial Institute for Ophthalmic Research
Giza, Giza Governorate
About this study
Official title: Comparison Between Conventional Non-Penetrating Deep Sclerectomy and Modified Technique With Subflap Mattress Suture in Patients With Open-Angle Glaucoma
The goal of this clinical trial is to learn if modified non-penetrating deep sclerectomy (NPDS) with a sub-flap mattress suture works to treat open-angle glaucoma (OAG). It will also learn about the safety and effectiveness of this modified surgical approach. The main questions it aims to answer are:
Does the modified NPDS technique result in significantly lower and more persistent intraocular pressure (IOP) reduction compared to the conventional technique? What is the rate of complete success (IOP 6-18 mmHg without medication) and qualified success (IOP 6-18 mmHg with medication) for both groups? What postoperative complications or medical problems (such as iris prolapse, conjunctival leaks, or IOP spikes) do participants experience?
Read more
Researchers will compare Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture to standard conventional NPDS to see which technique provides better long-term pressure control.
Participants will be randomized into two groups and will:
Undergo either the standard NPDS procedure or the modified NPDS procedure using a 10/0 nylon mattress suture.
Visit the clinic for at least five scheduled follow-up appointments at 1 week, 1 month, 3 months, 6 months, and 9 months post-surgery.
Undergo comprehensive eye examinations at each visit, including Goldmann applanation tonometry for IOP, visual acuity testing, and monitoring for the development of cataracts or other surgical complications.
Read the detailed description
The surgical protocol for Non-Penetrating Deep Sclerectomy (NPDS) begins with standardized aseptic preparation using 10% and 5% Betadine, followed by peribulbar anesthesia. In the standard Group 1 procedure, a 4 mm x 4 mm superficial scleral flap is created after conjunctival dissection, and Mitomycin-C (0.2 mg/mL) is applied for two minutes to inhibit scarring. The core of the surgery involves dissecting a deeper scleral flap to 90% thickness, unroofing Schlemm's canal to expose the trabeculo-descemet's membrane (TDM) and allow for aqueous percolation. The deep flap is then excised, the superficial flap is sutured with 10/0 nylon, and the conjunctiva is closed with watertight 7/0 Vicryl sutures.
For Group 2, the standard NPDS steps were followed until the excision of the deep scleral flap, at which point a specific mattress suture modification is introduced. Utilizing the Abdel Rahman and Habib technique, a 10/0 nylon suture is threaded through the sclera 2 mm lateral to the flap borders in an anteroposterior and postero-anterior fashion, creating a mattress configuration beneath the superficial flap to maintain the filtration space. Postoperatively, both groups follow a strict regimen of topical moxifloxacin and prednisolone acetate, which is tapered over six weeks, alongside a five-day course of oral ciprofloxacin to prevent infection and manage inflammation.
- Conditions
- Open Angle Glaucoma (OAG)
- Being tested
- Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS), Conventional Nonpenetrating Deep Sclerectomy (NPDS)
- Keywords
- Open Angle Glaucoma (OAG), Nonpenetrating Deep Sclerotomy (NPDS), Sub-Flap Mattress sutures, Ahmed's Sutures
- 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.
Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS)Procedure or surgery
Up until the deep scleral flap was removed, this method was identical to the conventional NPDS. Applying a mattress suture beneath the superficial scleral flap was the next step. The superficial flap was sutured with a 10/0 nylon (Alcon®) that extended 1 mm beyond its outside edges. The methodology originally described by Abdel Rahman and Habib was followed by the placement method. The initial step in introducing the suture into the sclera was to line it with the left boundary of the superficial scleral flap and to do it in an anteroposterior manner. This was done 2 mm outside the flap. After that, it was moved horizontally under the flap again until it reached the right border. Then, it was threaded postero-anteriorly, 2 mm laterally to the right flap edge. Then, using McPherson forceps, the suture was fastened in a mattress configuration, with one limb placed near Schlemm's canal.
Conventional Nonpenetrating Deep Sclerectomy (NPDS)Procedure or surgery
The conjunctiva was made more visible by placing a 7/0 Vicryl corneal traction suture in the superior cornea. Wescott scissors were used to excise a 10 mm fornix-based conjunctival flap, and minimum diathermy was used to achieve haemostasis. Using a super blade, a 4 mm x 4 mm superficial scleral flap was made. Then, a crescent knife was used for anterior dissection to a depth of around 50% of the scleral thickness, exposing the top 2 mm of the transparent cornea. Under the scleral flap in the subconjunctival area, mitomycin-C (MMC®) sponges were positioned at a concentration of 0.2 mg/mL and moved towards the upper fornix. They were kept in place for 2 minutes. A balanced salt solution, volume 50 mL, was used for irrigation purposes. The scleral spur was located by dissecting a deep scleral flap that began at the superficial flap's perimeter and continued to a depth equal to 90% of the thickness of the scleral bed. To expose the trabecular meshwork (TDM), the roof of Schlemm's canal wa
| Study group | Role | What they receive |
|---|---|---|
| Group A (Conventional NPDS) | Active comparator | The standard procedure Receives: Procedure: Conventional Nonpenetrating Deep Sclerectomy (NPDS) |
| Group B (Modified NPDS) | Experimental | Modified NPDS with Ahmed's sub-flap mattress suture Receives: Procedure: Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
IOP was measured using Goldmann applanation tonometry (GAT) at baseline (1 day preoperative) and during the planned follow-up visits.
Measured: From baseline (1 day preoperative) to the five follow-up visits at one week, one month, three months, six months, and nine months.
Secondary outcomes (5)
The Percentage of Patients with Postoperative IOP within 6-18 mmHg without Medication
If the intraocular pressure (IOP) stayed within the 6-18 mmHg range without medication throughout the follow-up period, the surgical result was deemed a full success. Reaching the same intraocular pressure (IOP) range while using topical medicines was considered a qualified success. Failure was defined as the inability to meet any of these requirements, which might lead to problems that could impair vision or need more severe glaucoma surgery.
Measured: At one week, one month, three months, six months, and nine months postoperatively.
Best Corrected Visual Acuity (BCVA)
Measured using Snellen's chart to assess baseline BCVA and any changes following the surgical procedure.
Measured: From baseline 1 day preoperative and the five follow-up visits at one week, one month, three months, six months, and nine months.
Postoperative Complications
Postoperative complications, such as iris prolapse, conjunctival leak, or IOP spikes, were assessed and compared between the two study groups.
Measured: At one week, one month, three months, six months, and nine months postoperatively.
Need for Reintervention
The need for intervention with bleb needling or YAG goniopuncture was assessed between the conventional and modified NPDS groups.
Measured: At one week, one month, three months, six months, and nine months postoperatively.
Postoperative Medication
The use of postoperative medications was evaluated and reported in the form of 'no drugs', 'one drug,' or 'two drugs' between the two study groups.
Measured: At one week, one month, three months, six months, and nine months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start7 Nov 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma (OAG)Studies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Amr Taha Orabi, Beni-Suef University
- Investigators
- Amr Taha Orabi, Principal investigator, Beni-Suef UniversityMohamed Sayed Abouzeid, MD, Study director, Beni-Suef UniversityHazem Haroun, Study chair, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425743
- Sponsor's protocol ID
- FMBSUREC/06112022/Orabi
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conventional Non-Penetrating Deep Sclerectomy and Modified Technique With Subflap Mattress Suture in Patients With Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT07425743
- Acronym / sponsor ID
- FMBSUREC/06112022/Orabi
- Conditions
- Open Angle Glaucoma (OAG)
- Keywords
- Open Angle Glaucoma (OAG), Nonpenetrating Deep Sclerotomy (NPDS), Sub-Flap Mattress sutures, Ahmed's Sutures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 23 Feb 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.
The goal of this clinical trial is to learn if modified non-penetrating deep sclerectomy (NPDS) with a sub-flap mattress suture works to treat open-angle glaucoma (OAG). It will also learn about the safety and effectiveness of this modified surgical approach. The main questions it aims to answer are:
Does the modified NPDS technique result in significantly lower and more persistent intraocular pressure (IOP) reduction compared to the conventional technique? What is the rate of complete success (IOP 6-18 mmHg without medication) and qualified success (IOP 6-18 mmHg with medication) for both groups? What postoperative complications or medical problems (such as iris prolapse, conjunctival leaks, or IOP spikes) do participants experience?
Researchers will compare Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture to standard conventional NPDS to see which technique provides better long-term pressure control.
Participants will be randomized into two groups and will:
Undergo either the standard NPDS procedure or the modified NPDS procedure using a 10/0 nylon mattress suture.
Visit the clinic for at least five scheduled follow-up appointments at 1 week, 1 month, 3 months, 6 months, and 9 months post-surgery.
Undergo comprehensive eye examinations at each visit, including Goldmann applanation tonometry for IOP, visual acuity testing, and monitoring for the development of cataracts or other surgical complications.
Detailed description
The surgical protocol for Non-Penetrating Deep Sclerectomy (NPDS) begins with standardized aseptic preparation using 10% and 5% Betadine, followed by peribulbar anesthesia. In the standard Group 1 procedure, a 4 mm x 4 mm superficial scleral flap is created after conjunctival dissection, and Mitomycin-C (0.2 mg/mL) is applied for two minutes to inhibit scarring. The core of the surgery involves dissecting a deeper scleral flap to 90% thickness, unroofing Schlemm's canal to expose the trabeculo-descemet's membrane (TDM) and allow for aqueous percolation. The deep flap is then excised, the superficial flap is sutured with 10/0 nylon, and the conjunctiva is closed with watertight 7/0 Vicryl sutures.
For Group 2, the standard NPDS steps were followed until the excision of the deep scleral flap, at which point a specific mattress suture modification is introduced. Utilizing the Abdel Rahman and Habib technique, a 10/0 nylon suture is threaded through the sclera 2 mm lateral to the flap borders in an anteroposterior and postero-anterior fashion, creating a mattress configuration beneath the superficial flap to maintain the filtration space. Postoperatively, both groups follow a strict regimen of topical moxifloxacin and prednisolone acetate, which is tapered over six weeks, alongside a five-day course of oral ciprofloxacin to prevent infection and manage inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Conventional NPDS) | Active comparator | Procedure: Conventional Nonpenetrating Deep Sclerectomy (NPDS)The standard procedure |
| Group B (Modified NPDS) | Experimental | Procedure: Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS)Modified NPDS with Ahmed's sub-flap mattress suture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary or secondary open-angle glaucoma (OAG), either uncontrolled or intolerant to medical therapy
Key exclusion criteria (1 listed)
- Past glaucoma procedures, including laser therapy, lens extraction, previous refractive surgery, angle closure, and neovascular glaucoma.
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 |
|---|---|---|
| Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS)Up until the deep scleral flap was removed, this method was identical to the conventional NPDS. Applying a mattress suture beneath the superficial scleral flap was the next step. The superficial flap was sutured with a 10/0 nylon (Alcon®) that extended 1 mm beyond its outside edges. The methodology originally described by Abdel Rahman and Habib was followed by the placement method. The initial step in introducing the suture into the sclera was to line it with the left boundary of the superficial scleral flap and to do it in an anteroposterior manner. This was done 2 mm outside the flap. After that, it was moved horizontally under the flap again until it reached the right border. Then, it was threaded postero-anteriorly, 2 mm laterally to the right flap edge. Then, using McPherson forceps, the suture was fastened in a mattress configuration, with one limb placed near Schlemm's canal. | Procedure or surgery | Group B (Modified NPDS) |
| Conventional Nonpenetrating Deep Sclerectomy (NPDS)The conjunctiva was made more visible by placing a 7/0 Vicryl corneal traction suture in the superior cornea. Wescott scissors were used to excise a 10 mm fornix-based conjunctival flap, and minimum diathermy was used to achieve haemostasis. Using a super blade, a 4 mm x 4 mm superficial scleral flap was made. Then, a crescent knife was used for anterior dissection to a depth of around 50% of the scleral thickness, exposing the top 2 mm of the transparent cornea. Under the scleral flap in the subconjunctival area, mitomycin-C (MMC®) sponges were positioned at a concentration of 0.2 mg/mL and moved towards the upper fornix. They were kept in place for 2 minutes. A balanced salt solution, volume 50 mL, was used for irrigation purposes. The scleral spur was located by dissecting a deep scleral flap that began at the superficial flap's perimeter and continued to a depth equal to 90% of the thickness of the scleral bed. To expose the trabecular meshwork (TDM), the roof of Schlemm's canal wa | Procedure or surgery | Group A (Conventional NPDS) |
Primary outcome
Intraocular Pressure (IOP)
Time frame: From baseline (1 day preoperative) to the five follow-up visits at one week, one month, three months, six months, and nine months.
IOP was measured using Goldmann applanation tonometry (GAT) at baseline (1 day preoperative) and during the planned follow-up visits.
5 secondary outcomes
The Percentage of Patients with Postoperative IOP within 6-18 mmHg without Medication
Time frame: At one week, one month, three months, six months, and nine months postoperatively.
Best Corrected Visual Acuity (BCVA)
Time frame: From baseline 1 day preoperative and the five follow-up visits at one week, one month, three months, six months, and nine months.
Postoperative Complications
Time frame: At one week, one month, three months, six months, and nine months postoperatively.
Need for Reintervention
Time frame: At one week, one month, three months, six months, and nine months postoperatively.
Postoperative Medication
Time frame: At one week, one month, three months, six months, and nine months postoperatively.
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 23 Feb 2026.
- 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.
Amr Taha Orabi principal investigator
Beni-Suef University
Mohamed Sayed Abouzeid, MD study director
Beni-Suef University
Hazem Haroun study chair
Beni-Suef University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS) and Conventional Nonpenetrating Deep Sclerectomy (NPDS) in people with Open Angle Glaucoma (OAG), run by Beni-Suef University at 2 sites 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 1 inclusion and 1 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Intraocular Pressure (IOP) (time frame: From baseline (1 day preoperative) to the five follow-up visits at one week, one month, three months, six months, and nine months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.