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

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.

Study Overview

• Status: Withdrawn
• Conditions: Primary Open Angle Glaucoma; Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliation Glaucoma in Both Eyes
• Intervention / Treatment: Procedure: Glaucoma and Cataract Surgery

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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:

  1. Primary open angle glaucoma (POAG).
  2. Pigmentary glaucoma.

  3. 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):

       1. Mild: MD no worse than -6 dB.
       2. Moderate: MD worse than -6 but no worse than -12 dB.
       3. Severe: MD worse than -12 dB.

Exclusion Criteria:

1. Glaucoma types rather than open angle glaucoma types mentioned in the inclusion criteria (Primary, Pigmentary and Pseudoexfoliation Glaucomas).
2. Any prior glaucoma, corneal or vitreoretinal surgery.
3. Evidence of concomitant retinal, optic nerve, or neurological diseases affecting the visual field.
4. Abnormal angle anatomy.
5. Prior Argon Laser Trabeculoplasty (ALT), Laser Iridotomy or Iridoplasty.
6. Any systemic condition or medications affectiong IOP.
7. Corneal opacity, corneal dystrophy or central corneal thickness (CCT) less than 480 or more than 620 microns.

8. 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:

   1. Visual Field: Mean deviation worse than -12 dB.
   2. Intraocular pressure: a treated IOP of greater than 24 mmHg.
   3. Medications: using more than three medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iStent; iStent Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery	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
Active Comparator: iStent Inject; iStent Inject Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery	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
Active Comparator: Hydrus; Hydrus Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP)	Reduction of IOP after eye surgery measured in millimeters of mercury (mmHg)	1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Change in visual acuity after eye surgery measured in minimal angle of resolution (logMAR).	1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12
Central Corneal Thickness (CCT)	Change in CCT after eye surgery measured in microns using pachymeter.	1 hour examination at Baseline, Months 3, 6 and 12
Endothelial Cell Count	Change in endothelial cell count after eye surgery measured in number of cells by millimeter square using specular microscopy.	1 hour examination at Baseline, Months 3, 6 and 12

Collaborators and Investigators

• Sponsor: Wills Eye
• Collaborators: Tanta Medical School, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): November 12, 2020
• Study Completion (Actual): November 12, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Uveal Diseases; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome
• Other Study ID Numbers: IRB #19-869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No