Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma

Phase 1

• Conditions: Congenital Glaucoma

• Registration Number: NCT01460017
• Lead Sponsor: King Saud University

Brief Summary

The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.

Detailed Description

Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.

Study Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-25
• Last Update Submitted: 2011-10-25
• Study First Posted: 2011-10-26
• Last Update Posted: 2011-10-26
• Study Start: 2011-11
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
• Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
• Within the age of (0 - 12).

Exclusion Criteria

• Cases of congenital glaucoma with previous intervention.
• Age above 12 Yrs.
• Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
reduction in IOP	6 month	decrease in the intraocular pressure to the normal limit (\<22 - \>6) mmHg

Trial Locations

Locations (1)

King Abdul Aziz University Hospital; 🇸🇦 Riyadh, Saudi Arabia