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Non-penetrating Deep Sclerectomy Versus Trabeculotomy- Trabeculectomy Operation in Treatment of Primary Congenital Glaucoma

Non-penetrating Deep Sclerectomy Versus Trabeculotomy- Trabeculectomy Operation in Treatment of Primary Congenital Glaucoma

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06189326
Enrollment
40
Registered
2024-01-03
Start date
2022-02-01
Completion date
2024-02-01
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Glaucoma

Brief summary

The high success rate of the non-penetrating deep sclerectomy (NPDS) procedure in adult glaucomatous patients motivated some glaucoma specialists to try it as an alternative procedure in childhood PCG. In deep sclerectomy, the surgeon fashions a partial-thickness scleral flap and excises the outer parts of both Schlemm's canal and trabecular meshwork without opening the eye, leaving a thin trabeculo-descemetic membrane. This membrane will guard against early postoperative hypotony due to the non-penetrating nature of the procedure. The aim of this study is to assess the safety and efficacy outcomes of non-penetrating deep sclerectomy versus combined trabeculotomy-trabeculectomy in the treatment of congenital primary glaucoma

Interventions

PROCEDUREnon-penetrating deep sclerectomy

Non-penetrating deep sclerectomy (NPDS) is a non-perforating filtration procedure used for the surgical treatment of medically uncontrolled open angle glaucoma. This procedure was developed in an attempt to avoid many of the postoperative complications of trabeculectomy

PROCEDUREprimary combined trabeculotomy-trabeculectomy

Combining trabeculotomy with trabeculectomy is one of the preferred surgical options, which showed favorable results in congenital glaucoma, and is advised mainly for treating moderate to severe forms of the disease, as the procedure provides dual pathways for aqueous drainage

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* patients with PCG younger than 6 years old with a HCD between 12-14 mm ware

Exclusion criteria

* patients with anterior segment anomalies, * secondary glaucoma * previous anterior segment surgeries * patients more than 6 years old

Design outcomes

Primary

MeasureTime frameDescription
Intra Occular PressureBase lineIntraocular pressure (IOP) is the fluid pressure of the eye. As pressure is a measure of force per area, IOP is a measurement involving the magnitude of the force exerted by the aqueous humor on the internal surface area of the anterior eye. It is measured by applanation tonometer its unite is mmHg

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026