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

This study has been completed.
Sponsor:
Information provided by:
Vanak Eye Surgery Center
ClinicalTrials.gov Identifier:
NCT00971061
First received: September 2, 2009
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Refractory Glaucoma
Device: Ahmed valve implant
Device: Molteno single-plate implant (MSPI)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vanak Eye Surgery Center:

Primary Outcome Measures:
  • Intra Ocular pressure (IOP) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra Ocular pressure (IOP) [ Time Frame: day 1,week 1, and months 1, 3, 6, 9, 12 and 18 ] [ Designated as safety issue: No ]
  • Changes in visual acuity [ Time Frame: day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24. ] [ Designated as safety issue: No ]
  • Number of anti-glaucoma medications [ Time Frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Mean deviation of visual field, [ Time Frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Rate of intra- and postoperative complications [ Time Frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: January 2003
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971061

Locations
Iran, Islamic Republic of
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00971061     History of Changes
Other Study ID Numbers: 1465087
Study First Received: September 2, 2009
Last Updated: September 3, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Vanak Eye Surgery Center:
Ahmed valve
single-plate Molteno implant
refractory glaucoma
surgical treatment

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014