Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensiv… (NCT02868190) | Clinical Trial Compass
CompletedPhase 4
Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication
Armenia57 participantsStarted 2013-03
Plain-language summary
This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle glaucoma on one topical hypotensive medication
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
Screening Exam Inclusion Criteria:
* Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs).
* Primary open-angle glaucoma (including pigmentary or pseudoexfoliative).
* Cup-to-disc ratio ≤ 0.9.
* Visual field defects, or nerve abnormality characteristic of glaucoma.
* One topical hypotensive medication at time of screening exam.
* Intraocular pressure (IOP) \> 18 mmHg and ≤ 30 mmHg (medicated) at screening exam.
* Study eye BCVA 20/100 or better.
* Normal angle anatomy as determined by gonioscopy.
* Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent.
Baseline Exam Inclusion Criteria:
* Subject has completed appropriate medication washout.
* Mean IOP \> 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period.
EXCLUSION CRITERIA:
Screening Exam Exclusion Criteria:
* Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs).
* Prior stent implantations (study eye).
* Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders.
* Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma.
* Prior incisional glaucoma surgery.
* Prior SLT within 90 days prior to screening.
* Prior ALT.
* Iridectomy or laser iridotomy.
* Ineligibility for ocular hypotensive medication washout period as determined by the investi…
What they're measuring
1
Mean intraocular pressure reduction of 20% or more vs baseline