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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Conventional NPDS) | Active Comparator | The standard procedure |
|
| Group B (Modified NPDS) | Experimental | Modified NPDS with Ahmed's sub-flap mattress suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture (modified NPDS) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | IOP was measured using Goldmann applanation tonometry (GAT) at baseline (1 day preoperative) and during the planned follow-up visits. | From baseline (1 day preoperative) to the five follow-up visits at one week, one month, three months, six months, and nine months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amr Taha Orabi | Beni-Suef University | Principal Investigator |
| Mohamed Sayed Abouzeid, MD | Beni-Suef University | Study Director |
| Hazem Haroun | Beni-Suef University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef University Hospital | Banī Suwayf | Beni Suweif Governorate | 62511 | Egypt | ||
| The Glaucoma Department at the Memorial Institute for Ophthalmic Research |
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|
| Conventional Nonpenetrating Deep Sclerectomy (NPDS) | Procedure | 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 |
|
| 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. | 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. | 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. | 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. | At one week, one month, three months, six months, and nine months postoperatively. |
| Giza |
| Giza Governorate |
| Egypt |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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