Assessing Visual Quality And Patient Satisfaction With An Iris-Fixated Presbyopia Correcting Phakic Iol: Insights From A Multicenter Clinical Trial
Published 2024 - 42nd Congress of the ESCRS
Reference: PP24.17 | Type: Free paper | DOI: 10.82333/6cq8-h657
Authors: Julián Cezón* 1 , José Güell 2 , R.M.M.A. Nuijts 3 , J.A. Durán de la Colina 4 , Mariano Royo Sans 5 , Choe Chul Myong 6 , Choi Tae Hoon 7 , Koh II Hwan 8 , Daniel Casado Rodríguez 9
1CIMO,Sevilla,Spain, 2IMO Instituto de Microcirugía Ocular,Barcelona,Spain, 3Maastricht UMC+,Maastricht,Netherlands, 4ICQO Instituto Clínico Quirúrgico de Oftalmología,Bilbao,Spain, 5Instituto Oftálmico de Madrid,Madrid,Spain, 6Nune Eye Hospital,Seoul,Korea, Republic Of, 7Nune Eye Hospital,Daegue,Korea, Republic Of, 8SU Yonsei Eye Clinic,Seoul,Korea, Republic Of, 9Visiondiez,Madrid,Spain
Purpose
To investigate whether the anterior chamber iris-fixated phakic multifocal IOL (Artiplus MF-PIOL, Ophtec, Groningen, NED) can provide satisfaction to postoperative patients after six months. The quality of vision provided by MF-PIOL in adult phakic subjects with presbyopia is being evaluated.
Setting
Nine clinical sites in three countries
Methods
Prospective, open-label, single-arm, multicenter clinical trial. Patient satisfaction and quality of vision (glare, halo’s, starburst, hazy vision, blurred vision, distortion, double vision, fluctuation of vision, focusing difficulties and difficulties with depth perception) were investigated by means of questionnaires.
Results
Forty-two patients enrolled. At 6-month follow-up, 98% expressed high satisfaction with procedure outcome and uncorrected vision. Also, 98% were confident in lens choice.
Regarding visual disturbances, majority rated them as not-at-all or mild: 95% no/mild glare, 90% no/mild halos, 85% no/mild starbursts, 86% no/mild hazy vision, 95% no/mild blurred vision, 95% no/mild distortion, 98% no/mild double vision, 88% no/mild fluctuation in vision, 95% no/mild focusing difficulties, and 93% no/mild difficulty judging distance or depth perception. A minority rated these as moderate to severe. Regarding driving, no daytime difficulties reported. 78% no nighttime issues, 22% minor night driving difficulties.
Conclusions
The anterior chamber iris-fixated phakic multifocal IOL (Artiplus MF-PIOL, Ophtec, Groningen, NED) demonstrates remarkable efficacy in providing visual quality and satisfaction among adult phakic subjects with presbyopia. Given that this is an interim analysis, updated results with longer follow-up data will be presented at a more advanced stage of the study.