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

Phase 1

• Conditions: Congenital Glaucoma
• Interventions: Procedure: Deep Sclerectomy; Procedure: Combined Trab

• 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

Arm && Interventions

Group	Intervention	Description
DS arm	Deep Sclerectomy	Deep sclerectomy surgery will be conduct in this arm
Trab arm	Combined Trab	combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm

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