Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
NCT Number: NCT04452279
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).
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Sioux Falls, South Dakota, 57108, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: iStent or iStent inject
Time frame: 3 months
Difference between preoperative and Month 3 mean OSDI score
Time frame: 3 months
Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia
Time frame: 3 months
Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia
Time frame: 3 months
Difference between preoperative and Month 3 mean FTBUT in seconds
Time frame: 3 months
Difference between preoperative and Month 3 mean IOP in mmHg
Time frame: 3 months
Difference between preoperative and Month 3 mean number of glaucoma medications
Vance Thompson Vision
Other
Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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