Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma

September 3, 2009 updated by: Vanak Eye Surgery Center
The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.

Exclusion Criteria:

  • age less than 40 years
  • a visual acuity of no light perception
  • lens opacity
  • elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
  • previous cyclodestructive treatment
  • increased risk of endophthalmitis posterior segment disorders
  • pre-existing ocular comorbidities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MSPI
Molteno single-plate implant
Device: Molteno single-plate implant (MSPI)
134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)
ACTIVE_COMPARATOR: AVI
Ahmed valve implant
Device: Ahmed valve implant
184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intra Ocular pressure (IOP)
Time Frame: Month 24
Month 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Intra Ocular pressure (IOP)
Time Frame: day 1,week 1, and months 1, 3, 6, 9, 12 and 18
day 1,week 1, and months 1, 3, 6, 9, 12 and 18
Changes in visual acuity
Time Frame: day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.
day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.
Number of anti-glaucoma medications
Time Frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24
week 1, and months 1, 3, 6, 9, 12, 18, and 24
Mean deviation of visual field,
Time Frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24
week 1, and months 1, 3, 6, 9, 12, 18, and 24
Rate of intra- and postoperative complications
Time Frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24
week 1, and months 1, 3, 6, 9, 12, 18, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanak Eye Surgery Center

Investigators

  • Principal Investigator: Nader Nassiri, MD, Assistant Professor, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
  • Principal Investigator: Nariman Nassiri, MD, Medical Researcher, Vanak Eye Surgery Center, Tehran, Iran
  • Principal Investigator: Ghazal Kamali, MD, 4th-year Resident, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

August 1, 2005

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (ESTIMATE)

September 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2009

Last Update Submitted That Met QC Criteria

September 3, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1465087

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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