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Completed

NCT Number: NCT00971061

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

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.

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Key information

Conditions

Refractory Glaucoma Eye Diseases Glaucoma Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanak Eye Surgery Center

Tehran, Tehran Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ahmed valve implant

Device

184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

Molteno single-plate implant (MSPI)

Device

134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)

Primary outcomes

  1. Intra Ocular pressure (IOP)

    Time frame: Month 24

Secondary outcomes

  1. Intra Ocular pressure (IOP)

    Time frame: day 1,week 1, and months 1, 3, 6, 9, 12 and 18

  2. Changes in visual acuity

    Time frame: day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.

  3. Number of anti-glaucoma medications

    Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24

  4. Mean deviation of visual field,

    Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24

  5. Rate of intra- and postoperative complications

    Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24

Sponsors and collaborators

Lead sponsor

Vanak Eye Surgery Center

Other

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 3, 2009
Registry last updated
Sep 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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