Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification

• Main Authors: Justin A. Schweitzer, Whitney H. Hauser, Mitch Ibach, Brandon Baartman, Subba R. Gollamudi, Andrew W. Crothers, John E. Linn, John P. Berdahl
• Format: Article
• Language: English
• Published: Adis, Springer Healthcare 2020-08-01
• Series: Ophthalmology and Therapy
• Subjects: Dry eye; Medication; MIGS; Ocular surface; Quality of life; Trabecular micro-bypass
• Online Access: https://doi.org/10.1007/s40123-020-00290-6
• ISSN: 2193-8245; 2193-6528

Abstract Introduction This study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Methods This prospective interventional single-arm clinical trial enrolled 47 eyes with mild-to-moderate open-angle glaucoma (OAG) on 1–4 glaucoma medications who underwent phacoemulsification and trabecular micro-bypass stent(s) implantation. Key glaucoma and ocular surface data through 3 months postoperatively included the Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), conjunctival hyperemia (Efron Scale), glaucoma medications, and intraocular pressure (IOP). Results Mean OSDI scores improved from 40.1 ± 21.6 (severe) preoperatively to 17.5 ± 15.3 (mild) at 3 months (p < 0.0001). While 73% of eyes had moderate or severe OSDI scores preoperatively, 29% had such scores at 3 months, and the OSDI score was normal in 57% of eyes versus 9% preoperatively. Mean FTBUT increased from 4.3 ± 2.4 s preoperatively to 6.4 ± 2.5 s at 3 months (p < 0.0001); mean Oxford corneal/conjunctival staining reduced from 1.4 ± 1.0 preoperatively to 0.4 ± 0.6 at 3 months (p < 0.0001); mean Efron conjunctival hyperemia score reduced from 1.4 ± 0.7 preoperatively to 1.2 ± 0.6 at 3 months (p = 0.118). The number of glaucoma medications decreased from 1.5 ± 0.9 to 0.6 ± 0.8 mean medications (60% reduction, p < 0.0001), with all eyes maintaining or reducing medications versus preoperatively and 55% of eyes becoming medication-free (versus 0% preoperatively). Mean IOP reduced from 17.4 ± 4.2 mmHg to 14.5 ± 3.2 mmHg (p < 0.0001). The safety profile was excellent. Conclusion Implantation of trabecular micro-bypass stent(s) (iStent or iStent inject) with cataract surgery produced significant improvements in ocular surface health, alongside significant reductions in IOP and medications. Trial registration ClinicalTrials.gov identifier, NCT04452279.