NCT04202510

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

December 11, 2019

Last Update Submit

February 16, 2021

Conditions

Open Angle GlaucomaPrimary Open Angle GlaucomaPigmentary GlaucomaPseudoexfoliation Glaucoma in Both Eyes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Visual Acuity

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

  • Central Corneal Thickness (CCT)

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

  • Endothelial Cell Count

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

Study Arms (3)

iStent

ACTIVE COMPARATOR

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

iStent Inject

ACTIVE COMPARATOR

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

Hydrus

ACTIVE COMPARATOR

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

Interventions

Glaucoma and Cataract SurgeryPROCEDURE

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

HydrusiStentiStent Inject

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Daniel Lee, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 17, 2019

Study Start

January 6, 2020

Primary Completion

November 12, 2020

Study Completion

November 12, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)