Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

P

Peter Netland, MD

Status

Completed

Conditions

Glaucoma

Treatments

Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)
Device: Porous Plate Ahmed Glaucoma Valve (Model M4)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01883856
16051

Details and patient eligibility

About

The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.

Full description

The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.

Enrollment

52 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female of any race ≥ 18 years and ≤ 80 years of age.
  • Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.
  • Elevated intraocular pressure > 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.
  • Subject is a candidate for surgery in the study eye with a glaucoma drainage device.
  • Subject is willing and able to sign the informed consent.

Exclusion criteria

  • Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.
  • History of prior drainage implant surgery in the study eye.
  • History of cyclophotocoagulation of the study eye.
  • Pregnancy.
  • Prisoner.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Silicone Plate Ahmed Glaucoma Valve
Active Comparator group
Description:
Silicone plate Ahmed Glaucoma Valve
Treatment:
Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)
Porous Plate Ahmed Glaucoma Valve
Experimental group
Description:
Porous Plate Ahmed Glaucoma Valve
Treatment:
Device: Porous Plate Ahmed Glaucoma Valve (Model M4)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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