Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vance Thompson Vision
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Change in mean fluorescein tear break-up time (FTBUT)
Study Overview
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 undergo phacoemulsification and trabecular micro-bypass stent(s) implantation (iStent or iStent inject).
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 stent(s) implantation (iStent or iStent inject). Study participation entailed measurement of key ocular surface data through 3 months postoperative including Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), and conjunctival hyperemia (Efron Scale); these measures were collected alongside standard postoperative glaucoma evaluations such as number of glaucoma medications and intraocular pressure (IOP).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
- •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)
- •Fellow eye actively enrolled in this trial
- •Current participation in any study, or participation within 30 calendar days of screening exam
- •Unsuccessful, complicated cataract surgery
- •OSDI of 7 or less
Outcomes
Primary Outcomes
Change in mean fluorescein tear break-up time (FTBUT)
Time Frame: 3 months
Difference between preoperative and Month 3 mean FTBUT in seconds
Change in mean OSDI score
Time Frame: 3 months
Difference between preoperative and Month 3 mean OSDI score
Change in mean conjunctival hyperemia score
Time Frame: 3 months
Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia
Change in mean corneal/conjunctival staining score
Time Frame: 3 months
Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia
Secondary Outcomes
- IOP change(3 months)
- Medication change(3 months)