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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Dr. Ahmed Mousa, King Saud University.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Ahmed Mousa, King Saud University
ClinicalTrials.gov Identifier:
NCT01460017
First received: October 25, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose
The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.

Condition Intervention Phase
Congenital Glaucoma Procedure: Deep Sclerectomy Procedure: Combined Trab Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Ahmed Mousa, King Saud University:

Primary Outcome Measures:
  • reduction in IOP [ Time Frame: 6 month ]
    decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Combined Trabeculectomy Trabeculotomy

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.
  Eligibility

Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460017

Locations
Saudi Arabia
King Abdul Aziz University Hospital Not yet recruiting
Riyadh, Saudi Arabia, 11411
Contact: Saleh A. Al-Obeidan, MD    +96614786100 ext 1425    alobeidan@yahoo.com   
Contact: Essam A. Osman, FRCS    +966507449080    essam.osman065@gmail.com   
Sub-Investigator: Essam A. Osman, FRCS         
Sub-Investigator: Ahmed M Abdel-Rahim, Ph. D.         
Sponsors and Collaborators
King Saud University
Investigators
Principal Investigator: Saleh A. Al-Obeidan, MD King Saud University
  More Information

Responsible Party: Dr. Ahmed Mousa, Lecturer, King Saud University
ClinicalTrials.gov Identifier: NCT01460017     History of Changes
Other Study ID Numbers: E-11-487
Study First Received: October 25, 2011
Last Updated: October 25, 2011

Additional relevant MeSH terms:
Glaucoma
Hydrophthalmos
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 21, 2017