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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocular Surface Disease post-stenting | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent or iStent inject implantation with concomitant cataract surgery | Device | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Schweitzer, OD, FAAO | Vance Thompson Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32789800 | Derived | Schweitzer JA, Hauser WH, Ibach M, Baartman B, Gollamudi SR, Crothers AW, Linn JE, Berdahl JP. Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification. Ophthalmol Ther. 2020 Dec;9(4):941-953. doi: 10.1007/s40123-020-00290-6. Epub 2020 Aug 13. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| 3 months |