Glaucoma, Open-Angle, Ocular Surface Disease
Conditions
Keywords
ocular surface, dry eye, medication, quality of life
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).
Interventions
DEVICEiStent 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
Vance Thompson Vision
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean OSDI score | 3 months | Difference between preoperative and Month 3 mean OSDI score |
| Change in mean conjunctival hyperemia score | 3 months | Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia |
| Change in mean corneal/conjunctival staining score | 3 months | Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia |
| Change in mean fluorescein tear break-up time (FTBUT) | 3 months | Difference between preoperative and Month 3 mean FTBUT in seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP change | 3 months | Difference between preoperative and Month 3 mean IOP in mmHg |
| Medication change | 3 months | Difference between preoperative and Month 3 mean number of glaucoma medications |
Countries
United States
Outcome results
None listed