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

Congenital Glaucoma Clinical Trial

Official title:

Comparison Between The Outcome of Deep Sclerectomy and Traditional Trabeculotomy and Trabeculectomy Surgeries in Congenital Glaucoma

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01460017
• Other study ID #: E-11-487
• Status: Unknown status
• Phase: Phase 1
• First received: October 25, 2011
• Last updated: October 25, 2011
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2011
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Glaucoma
• Glaucoma

Intervention

Procedure:
• Deep Sclerectomy
Non penetrating glaucoma surgery is a new procedure in adults that has less post operative complications with good results, it is to be applied in children.
• Combined Trab
Combined trabeculectomy and trabeculotomy is a standard surgery for congenital glaucoma, however, it has its known complications.

Locations

Country	Name	City	State
Saudi Arabia	King Abdul Aziz University Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in IOP	decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg	6 month