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Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

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Glaukos

Status

Completed

Conditions

Open-angle Glaucoma

Treatments

Device: Two iStent
Device: One iStent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01455467
GCF-024

Details and patient eligibility

About

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
  • Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

Exclusion criteria

  • Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
  • Prior stent implantations (study eye)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

79 participants in 2 patient groups

One iStent
Active Comparator group
Description:
Implantation of one iStent in conjunction with cataract surgery
Treatment:
Device: One iStent
Two iStent
Active Comparator group
Description:
Implantation of two iStent devices in conjunction with cataract surgery
Treatment:
Device: Two iStent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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