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Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification

NCT04452279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2020-06-30

No results posted yet for this study

Summary

This prospective interventional single-arm trial evaluates measures changes in ocular surface disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation (iStent or iStent inject).

Conditions

  • Ocular Surface Disease
  • Glaucoma, Open-Angle

Interventions

DEVICE

iStent or iStent inject implantation with concomitant cataract surgery

Standard phacoemulsification cataract surgery followed by ab interno implantation of either iStent or iStent inject trabecular micro-bypass stent(s). Preoperatively and at specified visits through 3 months postoperative, patients will complete evaluations of their ocular surface disease (specifically OSDI score, hyperemia, corneal/conjunctival staining, and tear break-up time).

Sponsors & Collaborators

  • Vance Thompson Vision

    lead OTHER

Principal Investigators

  • Justin Schweitzer, OD, FAAO · Vance Thompson Vision

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-03-01
Completion
2019-08-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04452279 on ClinicalTrials.gov