NCT04202510

IOP and Medication Reduction in MIGS Procedures

Pressure Reduction and Medication Use Following Different Minimally Invasive Glaucoma Surgery Procedures, Prospective Randomized Clinical Trial of Efficacy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study Design Prospective Randomized Clinical Trial (Parallel Group Study) Patients who fit inclusion criteria will be randomly assigned to one of the 3 parallel groups (one of the study surgical interventions combined with phacoemulsification) in the following order: 1. 1st Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA). 2. 2nd Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA). 3. Hydrus Microstent (Ivantis Inc, Irvine, CA). Blocked randomization will be used in 1:1:1 ratio to provide balanced study groups. Allocation will be performed using a random number table. Preoperative Evaluation of : Visual acuity, Slit lamp examination, IOP, Gonioscopy, Fundus Examination, Central corneal thickness (CCT), Endothelial Cell Count (ECC), Visual field, Retinal Nerve Fiber layer (RNFL) thickness by Optical Coherence Tomography (OCT) and Number and type of preoperative antiglaucoma medications. Patients will be followed postoperatively at Day 1, Week 1, Months 1, 3, 6 and 12. Medication Washout will be done at baseline, Months 6 and 12 to evaluate non-medicated IOP. The duration of washout will be: 4 Weeks for Prostaglandin Analogues (PGA) and Beta Blockers (BB). 2 Weeks for Carbonic Anhydrase Inhibitors (CAI) and Alpha Agonists (AA). The IOP measurements in the wash out visits: will be performed according to 2-operator method to provide masking as described in Ocular Hypertension Treatment Study (OHTS) and Glaucoma World Association Guidelines.

Conditions

• Open Angle Glaucoma
• Primary Open Angle Glaucoma
• Pigmentary Glaucoma
• Pseudoexfoliation Glaucoma in Both Eyes

Interventions

Type	Name	Description
PROCEDURE	Glaucoma and Cataract Surgery	Patients requiring combined cataract and glaucoma surgery will be randomized to either iStent, iStent Inject or Hydrus (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2019-12-17
• Last updated: 2021-02-21

Locations

1 site across 1 country: United States