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

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ClinicalTrials.gov Identifier: NCT01460017
Recruitment Status : Unknown
Verified October 2011 by Dr. Ahmed Mousa, King Saud University.
Recruitment status was:  Not yet recruiting
First Posted : October 26, 2011
Last Update Posted : October 26, 2011
Sponsor:
Information provided by (Responsible Party):
Dr. Ahmed Mousa, King Saud University

Study Description
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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
Congenital Glaucoma 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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 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


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


Eligibility Criteria
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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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460017


Locations
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Saudi Arabia
King Abdul Aziz University Hospital
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
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Principal Investigator: Saleh A. Al-Obeidan, MD King Saud University
More Information
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Responsible Party: Dr. Ahmed Mousa, Lecturer, King Saud University
ClinicalTrials.gov Identifier: NCT01460017    
Other Study ID Numbers: E-11-487
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Glaucoma
Hydrophthalmos
Ocular Hypertension
Eye Diseases
 Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases