IOP and Medication Reduction in MIGS Procedures

Withdrawn before enrolling · Not applicable

Conditions studied: Open Angle Glaucoma, Primary Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma in Both Eyes

In brief

The primary objective of this research is to compare the efficacy of trabecular minimally invasive glaucoma surgery (MIGS) devices (iStent vs iStent Inject vs Hydrus) for intra ocular pressure (IOP) and anti-glaucoma medication reduction in open angle glaucoma.

Key facts

Study ID

NCT04202510

Run by

Wills Eye

People needed

0

Starts

2020-01-06

Expected to finish

2020-11-12

Last updated by the study team

2021-02-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Adult male or female aged 40 years or more. 2. Patients able and willing to provide informed consent. 3. Patients having Visually Significant Age Related Cataract with Mild to Moderate Open Angle Glaucoma (OAG) on topical anti-glaucoma medication with or without previous Selective Laser Trabeculoplasty (SLT) ), including:
• Primary open angle glaucoma (POAG).
• Pigmentary glaucoma.
• Pseudoexfoliative glaucoma. 4. Patients should be candidate for safe mediaction wash out in the opinion of the investigator.
• The diagnosis of glaucoma is confirmd by optic nerve examination and the characteristic visual field defects on automated perimetry according to the American Academy of Ophthalmology (AAO) Definition and Criteria.
• The severity of glaucoma is classified using the Hodapp Parrish Anderson Visual Field Criteria depending on the Mean Deviation (MD):
• Mild: MD no worse than -6 dB.
• Moderate: MD worse than -6 but no worse than -12 dB.
• Severe: MD worse than -12 dB.

You may not qualify if…

• Glaucoma types rather than open angle glaucoma types mentioned in the inclusion criteria (Primary, Pigmentary and Pseudoexfoliation Glaucomas).
• Any prior glaucoma, corneal or vitreoretinal surgery.
• Evidence of concomitant retinal, optic nerve, or neurological diseases affecting the visual field.
• Abnormal angle anatomy.
• Prior Argon Laser Trabeculoplasty (ALT), Laser Iridotomy or Iridoplasty.
• Any systemic condition or medications affectiong IOP.
• Corneal opacity, corneal dystrophy or central corneal thickness (CCT) less than 480 or more than 620 microns.
• Exclusion from medications wash out according to the opinion of the investigator Or if any of the following is observed at any time point of the study:
• Visual Field: Mean deviation worse than -12 dB.
• Intraocular pressure: a treated IOP of greater than 24 mmHg.
• Medications: using more than three medications.

Where it is running

• Wills Eye Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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