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

Vance Thompson Vision47 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ocular Surface Disease Glaucoma, Open-Angle

Interventions

iStent or iStent inject implantation with concomitant cataract surgeryDEVICE

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).

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Mild to moderate primary open-angle glaucoma 2. Currently treated with ocular hypotensive medication 3. Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses 4. Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent 5. 22 years of age or older 6. Able and willing to attend scheduled follow-up exams for three months postoperatively 7. Able and willing to provide written informed consent on the IRB approved Informed Consent Form 8. Successful, uncomplicated cataract surgery 9. OSDI of 8 or more Exclusion Criteria: * 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: 1. Cataract surgery 2. Stent implantation 3. 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

Locations (1)

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

Change in mean OSDI score

Difference between preoperative and Month 3 mean OSDI score

Time frame: 3 months

Change in mean conjunctival hyperemia score

Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia

Time frame: 3 months

Change in mean corneal/conjunctival staining score

Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia

Time frame: 3 months

Change in mean fluorescein tear break-up time (FTBUT)

Difference between preoperative and Month 3 mean FTBUT in seconds

Time frame: 3 months

Secondary Outcomes

IOP change

Difference between preoperative and Month 3 mean IOP in mmHg

Time frame: 3 months

Medication change

Difference between preoperative and Month 3 mean number of glaucoma medications

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.