ESCRS - PP27.02 - Evaluation Of Prowl Questionnaire And Visual Outcomes After A Lenticule Procedure With Elita Femtosecond Laser System

Evaluation Of Prowl Questionnaire And Visual Outcomes After A Lenticule Procedure With Elita Femtosecond Laser System

Published 2023 - 41st Congress of the ESCRS

Reference: PP27.02 | Type: Free paper | DOI: 10.82333/bw76-4525

Authors: Raghav Malik 1 , Mahipal Sachdev* 1 , Rohit Shetty 2 , Brian Schwam 3 , Pooja Khamar 2 , Ritika Sachdev 1 , Michal Laron 4 , Andrew Voorhees 4 , Hong Fu 4 , Ying Wang 4 , Alejandra Gonzalez Calle 4 , Priya Janakiraman 4 , Luis Vargas 4

1Centre For Sight,Delhi,India, 2Narayan Nethralaya,Bengaluru,India, 3JJSV,Jacksonville,United States, 4JJSV,Milpitas,United States

Purpose

Johnson & Johnson Surgical Vision has developed the ELITA femtosecond laser system. This clinical trial evaluated patient satisfaction with the ELITA lenticule procedure and visual outcomes for myopic refractive correction with or without astigmatism up to 12-months post-operatively.

 

Setting

This clinical trial is part of a new femtosecond laser development project (ELITA) and is performed at 2 clinical sites in India. This is a single arm, bilateral prospective treatment study involving subjects 18 years or older with myopia with or without astigmatism.

 

Methods

A single arm, bilateral, prospective study in myopic subjects ≥18 years from 2 clinical sites was performed. 170 myopic subjects were treated binocularly for vision correction using the ELITA system. To evaluate patient satisfaction, the PROWL questionnaire was administered. 4 questions are presented here,  at 3, 6, 9, and 12M post-op, pertaining to satisfaction with the procedure & if one would recommend the procedure to a friend. The FDA PROWL questionnaire uses the word LASIK. Since the questionnaire was used to evaluate feedback from a lenticule procedure, patients were told to answer the question based on the procedure they received. Visual outcomes reported in this study are UCVA and MRSE upto the 12-month postoperative visit.

 

Results

Responses from 69,62, 63 & 8 patients were analysed at 3,6,9&12M post-op. At these time-points, 100%, 95%, 98% and 100% of patients were satisfied with the results; 99%, 94%, 95% and 100% were satisfied with how long it took to see improvements in their vision; 100%, 98%, 98% and 100% were happy that they had the procedure; and 96%, 98%, 97% and 100% would recommend the procedure to a friend. For visual outcomes analysis 158,130,138,124&16 eyes were available at 1W,1,3,6,9,12M. UCVA of 20/20 or better was achieved in 85%, 91%, 96%, 96%, 95% and 100% of eyes at these visits. BCVA of 20/20 or better was achieved in 100% of eyes after the 3M post-op. MRSE within ±0.50 D was achieved in 89%, 89%, 94%, 91%, 90% and 94% of eyes at the same visits

Conclusions

These results demonstrate patients treated with the ELITA femtosecond laser system are happy with the lenticule removal procedure and have excellent visual outcomes.