Status:
COMPLETED
Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification
Lead Sponsor:
Vance Thompson Vision
Conditions:
Ocular Surface Disease
Glaucoma, Open-Angle
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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...
Detailed Description
This study enrolled eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who were scheduled to undergo phacoemulsification cataract extraction and trabecular micro-bypass s...
Eligibility Criteria
Inclusion
- Mild to moderate primary open-angle glaucoma
- Currently treated with ocular hypotensive medication
- Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
- Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent
- 22 years of age or older
- Able and willing to attend scheduled follow-up exams for three months postoperatively
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
- Successful, uncomplicated cataract surgery
- OSDI of 8 or more
Exclusion
- 1\. Primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma 2. Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
- Cataract surgery
- Stent implantation
- Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits) 3. Fellow eye actively enrolled in this trial 4. Current participation in any study, or participation within 30 calendar days of screening exam 5. Unsuccessful, complicated cataract surgery 6. OSDI of 7 or less
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04452279
Start Date
May 1 2018
End Date
August 15 2019
Last Update
June 30 2020
Active Locations (1)
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1
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108