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Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft

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ClinicalTrials.gov Identifier: NCT03551834
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Glaucoma Other: Conventional scleral patch graft glaucoma implantation Other: New surgical method (short tunnel small flap technique) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft
Actual Study Start Date : January 20, 2017
Actual Primary Completion Date : September 20, 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: doing scleral patch graft glaucoma implantation Other: Conventional 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 Other: New surgical method (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.




Primary Outcome Measures :
  1. Intraocular pressure(IOP) [ Time Frame: 12 months post operatively ]
    Goldmann applanation tonometry

  2. Tube exposure [ Time Frame: 12 months post operatively ]
    slit lamp examination


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT03551834


Contacts
Contact: Mohammad Pakravan, MD 009822591616 labbafi@hotmail.com

Locations
Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad Pakravan, MD    009822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

Responsible Party: Zahra Rabbani Khah, Clinical Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03551834     History of Changes
Other Study ID Numbers: 97122
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases