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

Sponsor
King Saud University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01460017
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
25
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Deep Sclerectomy
  • Procedure: Combined Trab
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Comparison Between The Outcome of Deep Sclerectomy and Traditional Trabeculotomy and Trabeculectomy Surgeries in Congenital Glaucoma
Study Start Date :
Nov 1, 2011
Anticipated Primary Completion Date :
Nov 1, 2013
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. reduction in IOP [6 month]

      decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King Abdul Aziz University Hospital Riyadh Saudi Arabia 11411

    Sponsors and Collaborators

    • King Saud University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Ahmed Mousa, Lecturer, King Saud University
    ClinicalTrials.gov Identifier:
    NCT01460017
    Other Study ID Numbers:
    • E-11-487
    First Posted:
    Oct 26, 2011
    Last Update Posted:
    Oct 26, 2011
    Last Verified:
    Oct 1, 2011
    Additional relevant MeSH terms:
    Glaucoma
    Hydrophthalmos

    Study Results

    No Results Posted as of Oct 26, 2011