Back to results

IOP and Medication Reduction in MIGS Procedures

Primary Purpose

Open Angle Glaucoma, Primary Open Angle Glaucoma, Pigmentary Glaucoma

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Glaucoma and Cataract Surgery

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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:
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.

Sites / Locations

Wills Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

iStent

iStent Inject

Hydrus

Arm Description

iStent Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery

iStent Inject Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery

Hydrus Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)

Reduction of IOP after eye surgery measured in millimeters of mercury (mmHg)

Secondary Outcome Measures

Visual Acuity

Change in visual acuity after eye surgery measured in minimal angle of resolution (logMAR).

Central Corneal Thickness (CCT)

Change in CCT after eye surgery measured in microns using pachymeter.

Endothelial Cell Count

Change in endothelial cell count after eye surgery measured in number of cells by millimeter square using specular microscopy.

Full Information

NCT ID

NCT04202510

First Posted

December 11, 2019

Last Updated

February 16, 2021

Sponsor

Wills Eye

Collaborators

Tanta Medical School, Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04202510

Brief Title

IOP and Medication Reduction in MIGS Procedures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Due to COVID-19 and the decrease in surgical cases, sufficient patients were not available.

Study Start Date

January 6, 2020 (Actual)

Primary Completion Date

November 12, 2020 (Actual)

Study Completion Date

November 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wills Eye

Collaborators

Tanta Medical School, Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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: 1st Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA). 2nd Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iStent

Arm Type

Active Comparator

Arm Description

iStent Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery

Arm Title

iStent Inject

Arm Type

Active Comparator

Arm Description

iStent Inject Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery

Arm Title

Hydrus

Arm Type

Active Comparator

Arm Description

Hydrus Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery

Intervention Type

Procedure

Intervention Name(s)

Glaucoma and Cataract Surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

Intraocular Pressure (IOP)

Description

Reduction of IOP after eye surgery measured in millimeters of mercury (mmHg)

Time Frame

1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12

Secondary Outcome Measure Information:

Title

Visual Acuity

Description

Change in visual acuity after eye surgery measured in minimal angle of resolution (logMAR).

Time Frame

1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12

Title

Central Corneal Thickness (CCT)

Description

Change in CCT after eye surgery measured in microns using pachymeter.

Time Frame

1 hour examination at Baseline, Months 3, 6 and 12

Title

Endothelial Cell Count

Description

Change in endothelial cell count after eye surgery measured in number of cells by millimeter square using specular microscopy.

Time Frame

1 hour examination at Baseline, Months 3, 6 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Lee, MD

Organizational Affiliation

Wills Eye Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wills Eye Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

IOP and Medication Reduction in MIGS Procedures

We'll reach out to this number within 24 hrs