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

Primary Purpose

Refractory Glaucoma

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ahmed valve implant
Molteno single-plate implant (MSPI)
Sponsored by
Vanak Eye Surgery Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Glaucoma focused on measuring Ahmed valve, single-plate Molteno implant, refractory glaucoma, surgical treatment

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanak Eye Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MSPI

AVI

Arm Description

Molteno single-plate implant

Ahmed valve implant

Outcomes

Primary Outcome Measures

Intra Ocular pressure (IOP)

Secondary Outcome Measures

Intra Ocular pressure (IOP)
Changes in visual acuity
Number of anti-glaucoma medications
Mean deviation of visual field,
Rate of intra- and postoperative complications

Full Information

First Posted
September 2, 2009
Last Updated
September 3, 2009
Sponsor
Vanak Eye Surgery Center
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1. Study Identification

Unique Protocol Identification Number
NCT00971061
Brief Title
Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanak Eye Surgery Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Glaucoma
Keywords
Ahmed valve, single-plate Molteno implant, refractory glaucoma, surgical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSPI
Arm Type
Experimental
Arm Description
Molteno single-plate implant
Arm Title
AVI
Arm Type
Active Comparator
Arm Description
Ahmed valve implant
Intervention Type
Device
Intervention Name(s)
Ahmed valve implant
Intervention Description
184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
Intervention Type
Device
Intervention Name(s)
Molteno single-plate implant (MSPI)
Intervention Description
134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)
Primary Outcome Measure Information:
Title
Intra Ocular pressure (IOP)
Time Frame
Month 24
Secondary Outcome Measure Information:
Title
Intra Ocular pressure (IOP)
Time Frame
day 1,week 1, and months 1, 3, 6, 9, 12 and 18
Title
Changes in visual acuity
Time Frame
day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.
Title
Number of anti-glaucoma medications
Time Frame
week 1, and months 1, 3, 6, 9, 12, 18, and 24
Title
Mean deviation of visual field,
Time Frame
week 1, and months 1, 3, 6, 9, 12, 18, and 24
Title
Rate of intra- and postoperative complications
Time Frame
week 1, and months 1, 3, 6, 9, 12, 18, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Nassiri, MD
Organizational Affiliation
Assistant Professor, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nariman Nassiri, MD
Organizational Affiliation
Medical Researcher, Vanak Eye Surgery Center, Tehran, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ghazal Kamali, MD
Organizational Affiliation
4th-year Resident, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanak Eye Surgery Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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