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

Justin A Schweitzer, Whitney H Hauser, Mitch Ibach, Brandon Baartman, Subba R Gollamudi, Andrew W Crothers, John E Linn, John P Berdahl, Justin A Schweitzer, Whitney H Hauser, Mitch Ibach, Brandon Baartman, Subba R Gollamudi, Andrew W Crothers, John E Linn, John P Berdahl

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.

Keywords: Dry eye; MIGS; Medication; Ocular surface; Quality of life; Trabecular micro-bypass.

Figures

Fig. 1
Fig. 1
a Ocular Surface Disease Index (OSDI). b Oxford schema for corneal and conjunctival staining. c Efron Scale for conjunctival hyperemia. d Sample images of fluorescein tear break-up time (FTBUT) assessmenta. Footnote: aFTBUT classifications: normal, ≥ 10 s; mild to moderate, 5–9 s; severe, < 5 s
Fig. 2
Fig. 2
a Mean Ocular Surface Disease Index (OSDI) score. Preoperative vs. month 3. b Proportional analysis of OSDI score. Preoperative vs. month 3
Fig. 3
Fig. 3
a Mean fluorescein tear break-up time (FTBUT). Preoperative vs. month 3. b Mean corneal/conjunctival staining (Oxford Schema). Preoperative vs. month 3. c Mean conjunctival hyperemia (Efron score). Preoperative vs. month 3
Fig. 4
Fig. 4
a Mean number of medications. Preoperative vs. month 3. b Change in medication burden at 3 months vs. preoperativelya. Footnotes: aAt 3 months postoperatively, 100% of eyes either maintained or reduced medication burden vs. preoperatively. Preop, preoperative; Med, medication. c Proportional analysis of medication burden. Preoperative vs. month 3
Fig. 5
Fig. 5
Mean intraocular pressure (IOP). Preoperative vs. month 3

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