Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedSeptember 4, 2009
September 1, 2009
2.6 years
September 2, 2009
September 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intra Ocular pressure (IOP)
Month 24
Secondary Outcomes (5)
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
Study Arms (2)
MSPI
EXPERIMENTALMolteno single-plate implant
AVI
ACTIVE COMPARATORAhmed valve implant
Interventions
184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)
Eligibility Criteria
You may qualify if:
- refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanak Eye Surgery Center
Tehran, Tehran Province, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 3, 2009
Study Start
January 1, 2003
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
September 4, 2009
Record last verified: 2009-09