Overall Satisfaction in Patients Implanted With Hydrogel Corneal Inlay
Narrative Responses:
Purpose
To evaluate overall satisfaction in patients unilaterally implanted with a hydrogel corneal inlay (Raindrop, Revision Optics, Inc.). This empirical data review will look at various endpoints that influence postoperative patient satisfaction.
Methods
As part of a multi-center prospective FDA IDE study, 50 of 83 subjects from one clinical site have reached the 6M visit. ETDRS visual acuitives were collected at various distances preoperative, 1W, 1M, 3M, and 6M postoperative. Visual symptoms, visual task performance, and patient satisfaction wre evaluated via patient response including the validated NEI Quality of Life questionnaire.
Results
Binocularly, 100% of patients were 20/25 or better (UNVA) by 6M and 100% 20/20 or better (UDVA) by 1W. Monocularly, 98% of patients were 20/25 or better (UNVA) at 1M and 79% of patients were 20/25 or better (UDVA) at 6M. No reports of visual symptoms (i.e. halos, glare) occurred at 6 M. NEI questionnaire showed large increase for near task functionality (no gasses for long reading): 0% preop to 74% 6M, and little chage for distance task (no difficulty driving at night): 76% preop to 68% 6M. Overall patient satifaction was high at 92% being satisfied or very satisfied.
Conclusion
This hydrogel corneal inlay (Raindrop) provided most patients with good near acuity to perform daily tasks without glasses. Binocular distance acuity remains unchanged from preop and provided consistent distance task performance. A summation of improved near visual performance and no visual symptoms ultimately achieved high patient satisfaction of 92%.