Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma
This study is not yet open for participant recruitment.
Verified October 2011 by King Saud University
Sponsor:
King Saud University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) 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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by King Saud University:
Primary Outcome Measures:
- reduction in IOP [ Time Frame: 6 month ] [ Designated as safety issue: No ]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 |
| Genders Eligible for Study: | Both |
| 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
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
No publications provided
| 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 |
| Health Authority: | Saudi Arabia: Ministry for Higher Education |
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 May 19, 2013