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

Sponsor

Vanak Eye Surgery Center (Other)

Overall Status

Completed

CT.gov ID

NCT00971061

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Glaucoma	Device: Ahmed valve implant Device: Molteno single-plate implant (MSPI)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Intra Ocular pressure (IOP) [Month 24]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanak Eye Surgery Center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

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