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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery

Conditions
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Ocular Surface Disease, Glaucoma, Open-Angle

Intervention / Treatment
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* Device: iStent or iStent inject implantation with concomitant cataract surgery


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ocular Surface Disease post-stenting<br>Eyes will undergo phacoemulsification cataract surgery combined with iStent or iStent inject implantation according to standard clinical practice. From baseline through 3 months postoperatively, participants will complete subjective and objective assessments of ocular surface disease. | Device: iStent or iStent inject implantation with concomitant cataract surgery<br>* 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).<br>* Other names: iStent or iStent inject;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean OSDI score | Difference between preoperative and Month 3 mean OSDI score | 3 months | 
| Change in mean conjunctival hyperemia score | Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia | 3 months | 
| Change in mean corneal/conjunctival staining score | Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia | 3 months | 
| Change in mean fluorescein tear break-up time (FTBUT) | Difference between preoperative and Month 3 mean FTBUT in seconds | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change | Difference between preoperative and Month 3 mean IOP in mmHg | 3 months | 
| Medication change | Difference between preoperative and Month 3 mean number of glaucoma medications | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular surface, dry eye, medication, quality of life