- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551834
Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft
Glaucoma implants have been used for refractory glaucoma and are gaining popularity as a primary procedure in selected patients. In order to prevent tube erosion, a biologic material such as pericardium, cornea, and sclera is used as coverage over the tube. Despite this preventive measures, patch graft thinning and silicon tube exposure are still a serious complications and may occur in 1%-7% of eyes after glaucoma implantation. In this study we used a novel technique named short tunnel small flap (STSF) by tunneling the sclera without using any biological material . efficacy and safety of this technique is comparing with conventional scleral patch graft.
This randomized clinical trial, was performed at the Glaucoma Clinic of Labbafinejad Medical Center, Tehran, IRAN from September 2015 to January 2017 . The study was approved by the ethics committee at the Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran and followed the tenets of the Declaration of Helsinki. After explaining all therapeutic options and their side effects, the written consent form was obtained from all patient. 80 eyes of 80 patients with refractory glaucoma underwent AGV implantation by short tunnel small flap technique (group1) or scleral patch graft (group2) randomly. Primary outcome measure is Intraocular pressure(IOP) and Tube exposure, and secondary outcome measure is success rate that is defined as intraocular pressure (IOP) > 5 mmHg, ≤ 21 mmHg, and IOP reduction ≥ 20% from baseline at two consecutive visits after three months, no reoperation for glaucoma. Outcome measures are compared at 1, 3 , 6 and 12 months postoperatively.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Mohammad Pakravan, MD
- Phone Number: 009822591616
- Email: labbafi@hotmail.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Ophthalmic Research Center
-
Contact:
- Mohammad Pakravan, MD
- Phone Number: 009822591616
- Email: labbafi@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Iranian patients with Caucasian ethnicity, and at least 25 years old who had inadequately controlled glaucoma.
Exclusion Criteria:
- Primary congenital glaucoma, thin sclera, no light perception vision, pregnant or nursing women, iridocorneal endothelial syndrome, epithelial or fibrous down growth, and unwillingness to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: doing scleral patch graft glaucoma implantation
|
conventional AGV implantation by using scleral patch graft to cover the tube and prevent tube exposure
|
ACTIVE_COMPARATOR: Using short tunnel small flap technique
|
a novel technique named short tunnel small flap (STSF) by tunneling the sclera to pass the AGV tube without using scleral patch graft.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular pressure(IOP)
Time Frame: 12 months post operatively
|
Goldmann applanation tonometry
|
12 months post operatively
|
Tube exposure
Time Frame: 12 months post operatively
|
slit lamp examination
|
12 months post operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success rate
Time Frame: 12 months
|
Success rate defined as intraocular pressure (IOP) > 5 mmHg, ≤ 21 mmHg, and IOP reduction ≥ 20% from baseline at two consecutive visits after three months, no reoperation for glaucoma
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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