Clinical Trials Logo
  1. Home
  2. Pigmentary Glaucoma
  3. NCT04202510

IOP and Medication Reduction in MIGS Procedures

Open Angle Glaucoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04202510
Study type Interventional
Source Wills Eye
Contact
Status Withdrawn
Phase N/A
Start date January 6, 2020
Completion date November 12, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Terminated NCT03611530 - CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma N/A
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Not yet recruiting NCT02868502 - Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02272569 - STARflo European Safety and Efficacy Study N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT00941525 - Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure Phase 4
Completed NCT00539526 - Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues Phase 4
Completed NCT00121147 - Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan N/A
Active, not recruiting NCT05035394 - Swedish Microinvasive Glaucoma Surgery Study (SMIGS) N/A
Completed NCT03450629 - Evaluation of Safety and Efficacy of PDP-716 Phase 3
Active, not recruiting NCT06061718 - Travoprost Intraocular Implant in Conjunction With Cataract Surgery Phase 3
Recruiting NCT05241938 - PSLT Compared to Prostaglandin Analogue Eye Drops N/A
Completed NCT01342406 - Effects of Selective Laser Trabeculoplasty on Aqueous Humor Dynamics
Completed NCT02250612 - SYL040012, Treatment for Open Angle Glaucoma Phase 2
Terminated NCT01983579 - TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection Phase 4
Completed NCT01937312 - Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue Phase 4
Completed NCT01937299 - Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z® Phase 4
Completed NCT01229982 - A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma Phase 2