Functional Outcomes Of An Iris-Fixated Presbyopia Correcting Phakic Iol(Artiplus)
Published 2024 - 42nd Congress of the ESCRS
Reference: PO1202 | Type: Free paper | DOI: 10.82333/7fgk-6e45
Authors: Jose L Guell* 1 , Rudy Nuijts 2 , J.A Duran de la Colina 3 , M Royo Sans 4 , choe chul myong 5 , rudy Nuijts 6 , choi tae hoon 7 , koh iiHwan 8 , D casado-rodriguez 9 , J Cezon 10
1imo,barcelona,Spain, 2UMC Maastricht,Maastricht,Netherlands, 3icqo,bilbao,Spain, 4Hospital san rafael,madrid,Spain, 5nune eye hospital seoul,seoul,Korea, Republic Of, 6UMC,Maastricht,Netherlands, 7nune eyehospital,daegue,Korea, Republic Of, 8su yonsei eye clinic,yonsei,Korea, Republic Of, 9Visiondiez,madrid,Spain, 10CIMO,Sevilla,Spain
Purpose
To evaluate the safety and efficacy of an anterior chamber iris-fixated phakic multifocal IOL (Artiflex Presbyopic MF-PIOL, Ophtec, Groningen, NED) in adult phakic subjects with presbyopia. It will be studied whether MF-PIOL can provide satisfactory near, intermediate, and distance vision in subjects who desire spectacle independence.
Setting
Prospective single-arm multicenter study in 9 centers in three countries
Methods
Prospective, open-label, single-arm, multicenter clinical trial. The main outcome parameters are postoperative corrected / uncorrected VA at distance, intermediate and near (LogMAR). Secondary outcome parameters are MRSE, defocus curve, ECC and IOP. Patient satisfaction and quality of vision will be measured by means of questionnaires.
Results
Forty-two patients have been enrolled in the trial. At 6-month follow-up, the mean monocular MRSE improved from -5.09 ± 2.36 D to -0.38 ± 0.30 D. Mean monocular UDVA improved from 0.97 ± 0.23 to 0.01 ± 0.08 LogMAR. Mean monocular CDVA remained stable (0.00 ± 0.09 versus -0.05 ± 0.06 LogMAR). Mean monocular UNVA improved from 0.53 ± 0.42 to 0.07 ± 0.09 LogMAR. Binocular CDVA and DCNVA were respectively -0.09 ± 0.06 and 0.01 ± 0.08. IOP levels remained within normal levels, levels of dysphotopsia were relatively low for MIOL implantation.
Conclusions
Our interim findings suggest great promise for ArtiPLUS with good efficacy and safety profiles as well as low rates of dysphotopsia. 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.