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

Refractory Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971061
• Other study ID #: 1465087
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2009
• Last updated: September 3, 2009
• Start date: January 2003
• Est. completion date: August 2005

Study information

• Verified date: September 2009
• Source: Vanak Eye Surgery Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Refractory Glaucoma

Intervention

Device:
• Ahmed valve implant
184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
• Molteno single-plate implant (MSPI)
134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Vanak Eye Surgery Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Vanak Eye Surgery Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra Ocular pressure (IOP)		Month 24	No
Secondary	Intra Ocular pressure (IOP)		day 1,week 1, and months 1, 3, 6, 9, 12 and 18	No
Secondary	Changes in visual acuity		day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.	No
Secondary	Number of anti-glaucoma medications		week 1, and months 1, 3, 6, 9, 12, 18, and 24	No
Secondary	Mean deviation of visual field,		week 1, and months 1, 3, 6, 9, 12, 18, and 24	No
Secondary	Rate of intra- and postoperative complications		week 1, and months 1, 3, 6, 9, 12, 18, and 24	Yes