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

October 25, 2011 updated by: Dr. Ahmed Mousa, King Saud University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11411
        • King Abdul Aziz University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Essam A. Osman, FRCS
        • Sub-Investigator:
          • Ahmed M Abdel-Rahim, Ph. D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DS arm
Deep sclerectomy surgery will be conduct in this arm
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.
Other Names:
  • Non penetrating DS
Active Comparator: Trab arm
combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm
Procedure: Combined Trab
Combined trabeculectomy and trabeculotomy is a standard surgery for congenital glaucoma, however, it has its known complications.
Other Names:
  • Combined Trabeculectomy Trabeculotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in IOP
Time Frame: 6 month
decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Investigators

  • Principal Investigator: Saleh A. Al-Obeidan, MD, King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 26, 2011

Last Update Submitted That Met QC Criteria

October 25, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-11-487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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