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Randomized Controlled Trial
. 2020 Apr;37(4):1664-1674.
doi: 10.1007/s12325-020-01288-z. Epub 2020 Mar 17.

New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study

Paolo Fogagnolo  1   2 , Eleonora Favuzza  3 , Daniele Marchina  4   5 , Michela Cennamo  3 , Roberto Vignapiano  3 , Chiara Quisisana  4   5 , Luca Rossetti  4   5 , Rita Mencucci  3
Affiliations
Randomized Controlled Trial

New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study

Paolo Fogagnolo et al. Adv Ther. 2020 Apr.

Abstract

Introduction: To evaluate the effects of a new lubricating, antioxidant solution (VisuEvo®) on dry eye disease (DED) in patients undergoing cataract surgery.

Methods: Patients requiring cataract surgery with either healthy ocular surface or mild DED (tear break-up time, TBUT > 7, Schirmer I test > 15 mm/5 min) were enrolled in this multicenter, open-label, randomized, prospective study. Scheduled visits were 2 weeks before surgery (screening), day of surgery (V0), week 1 (V1), and 2 (V2) after surgery. VisuEvo® was self-administered three times daily for the whole study duration (group A); the control group (group B) had no tear substitute administration. The primary endpoint was the change in TBUT over time; the secondary endpoints were changes in Ocular Surface Disease Index (OSDI), ocular surface staining, the Schirmer I test, and osmometry.

Results: A total of 45 patients were included (group A, 23; group B, 22; age 74 ± 8 years). At the screening, TBUT was similar between the groups (group A, 8.5 ± 1.8 s; group B, 7.8 ± 0.7, p = 0.11). At the scheduled visits, TBUT increase vs screening visit was significantly higher in group A: +1.2 s at V0, +1.4 s at V1, and +1.9 s at V2 (p < 0.01). Also, OSDI was significantly lower in group A at V0, V1, and V2 (p < 0.027). After surgery, corneal staining was absent in 65-78% of group A compared with 54-59% in group B. The two groups did not show any significant differences of osmometry and the Schirmer I test.

Conclusions: The ocular surface was more protected and quickly restored from surgery when VisuEvo® was used from 2 weeks preoperatively to 2 weeks postoperatively.

Trial registration: ClinicalTrials.gov identifier, NCT03833908.

Keywords: Cataract surgery; Dry eye disease; Lubricating eye drops; Ocular surface; Ophthalmology.

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Figures

Fig. 1
Fig. 1
Trend of TBUT (s) among study visits by study treatment group
Fig. 2
Fig. 2
Trend of OSDI Questionnaire Score among study visits by study treatment group
Fig. 3
Fig. 3
Distribution of patients assessed by staining grade with fluorescein by study group at Visit 1 and Visit 2 post-surgery
See this image and copyright information in PMC

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