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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Glaucoma | Procedure: Deep Sclerectomy Procedure: Combined Trab | Phase 1 |
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 |

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

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Ages Eligible for Study: | up to 12 Years (Child) |
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

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
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. |
Principal Investigator: | Saleh A. Al-Obeidan, MD | King Saud University |
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 |
Glaucoma Hydrophthalmos Ocular Hypertension Eye Diseases |
Eye Abnormalities Glaucoma, Open-Angle Congenital Abnormalities Infant, Newborn, Diseases |