ESCRS - O42 - FUNCTIONAL OUTCOMES OF ARTIPLUS MULTIFOCAL INTRAOCULAR LENS – INTERIM ANALYSIS

FUNCTIONAL OUTCOMES OF ARTIPLUS MULTIFOCAL INTRAOCULAR LENS – INTERIM ANALYSIS

Published 2023 - 27th ESCRS Winter Meeting

Reference: O42 | Type: Free Paper Submission | DOI: 10.82333/c2pn-wd43

Authors: José Luis Güell* 1 , Nuno Moura-Coelho 2 , Rudy MMA Nujits 3 , Julián Cezón 4 , Juan Antonio Durán de la Colina 5 , Mariano Royo Sans 6 , Chul-Myong Choe 7 , Tae Hoon Choi 8 , Jae Ho Choi 9 , So Hyang Chung 10 , Il Hwan Koh 11

1Head of the Cornea and Refractive Surgery Unit,IMO Barcelona Grupo Miranza,Barcelona,Spain;Ophthalmology,Universidad Autónoma de Barcelona,Barcelona,Spain;8Scientific Coordinator and Professor of the Cornea and Refractive Surgery Module,ESASO,Lugano,Switzerland, 2Cornea and Refractive Surgery Unit,IMO Barcelona Grupo Miranza,Barcelona,Spain;Ophthalmology,NOVA Medical School,Lisbon,Portugal, 3Director of the Cornea Clinic and the Center for Refractive Surgery,Maastricht UMC+,Maastricht,Netherlands, 4Clínica CIMO,Seville,Spain, 5ICQO Instituto Clínico Quirúrgico de Oftalmología,Bilbao,Spain, 6Head of Ophthalmology,San Rafael Hospital,Madrid,Spain, 7Nune Eye Hospital Seoul,Seoul,Korea, Republic Of, 8Nune Eye Hospital Daegue,Daegu,Korea, Republic Of, 9Nune Eye Hospital,Seoul,Korea, Republic Of, 10Seoul ST. Mary's Hospital,Seoul,Korea, Republic Of, 11SU Yonsei Eye Clinic,Seoul,Korea, Republic Of

Purpose

To evaluate the safety and efficacy of an anterior chamber iris-claw phakic multifocal IOL (ArtiPlus MIOL, Ophtec, Groningen, NED) in adult phakic subjects with presbyopia. It will be studied whether MIOL can provide satisfactory near, intermediate, and distance vision in subjects who desire spectacle independence.

Setting

Prospective single-arm multicenter study in 8 centers in three countries.

Methods

Prospective, open-label, single-arm, multicenter clinical trial. The main outcome parameters were corrected and uncorrected visual acuity for distance (CDVA/UDVA), for intermediate (CIVA/UIVA) and for near (CNVA/UNVA). Secondary outcome parameters are mean refractive spherical equivalent (MRSE), defocus curve, endothelial cell count (ECC) and intraocular pressure (IOP). Patient satisfaction and quality of vision was measured by means of questionnaires.

Results

Mean monocular UDVA improved from 1.10 ± 0.25 to 0.04 ± 0.11 LogMAR. Mean monocular CDVA remained stable (-0.03 ± 0.08 versus -0.02 ± 0.07 LogMAR). At 1 month follow-up the mean monocular UNVA improved from 0.59 ± 0.40 to 0.11 ± 0.22 LogMAR. IOP levels remained within normal levels. Patients did not report spectacles dependence for near activities. At subsequent visits, other clinical parameters will be measured.

Conclusion

Our early findings suggest great promise for ArtiPlus, with good efficacy and safety profiles, as well as high rates of spectacle independence. Given that this is an interim analysis, updated results with larger cohorts and longer follow-up data will be presented at a more advanced stage of the study.