Pilot Study Of Sphere And Toric Phakic Implantable Collamer Lenses To Correct Or Reduce Myopia With Presbyopia With Or Without Astigmatism
Published 2025 - 43rd Congress of the ESCRS
Reference: PP03.18 | Type: Free paper | DOI: 10.82333/ppdb-1j59
Authors: Luis Haro-Morlett* 1 , Angelica Hernandez-Solis 1 , Aldo Hernandez 1 , Arturo Ramirez-Miranda 1 , Alejandro Navas 1 , Enrique O. Graue-Hernandez 1
1Cornea and Refractive Surgery,Instituto de Oftalmologia Conde de Valenciana,Ciudad de Mexico,Mexico
Purpose
To evaluate the clinical performance of the investigational Toric and Sphere Implantable Collamer® Lens with Aspheric (EDOF) Optic to correct or reduce myopia with presbyopia with or without astigmatism.
Setting
This study was conducted at Asian Eye Institute in Makati City, Philippines under the oversight of Principal Investigator Robert Ang, MD.
Methods
This prospective, open-label clinical trial of a Toric and Sphere EDOF ICL was conducted at one site in the Philippines. A total of 94 eyes (47 phakic subjects) with stable refraction were implanted bilaterally with toric (TEDOF, +1.0D to +3.0D cyl power) and/or spherical (EDOF) ICLs and followed for 6 months. Patients with a history of sight threatening diseases or prior ocular surgery were excluded. Performance outcomes included uncorrected distance, intermediate and near visual acuity (UDVA, UIVA, UNVA), manifest refraction spherical equivalent (MRSE) prediction error, defocus and contrast sensitivity, astigmatism correction and patient reported outcomes.
Results
Six-month data of 92 eyes (66 toric and 26 spherical EDOF ICL eyes) of 46 subjects show binocular uncorrected mean VA of 0.05±0.07 for distance (UDVA), 0.01±0.08 for intermediate (UIVA) and 0.09±0.10 for near vision (UNVA). Postoperative mean MRSE was ‑0.02±0.33D at 6 months. In TEDOF eyes, preoperative and postoperative mean refractive cylinder (6 months) was 1.03±0.60D and 0.52±0.39D, respectively. In TEDOF eyes with ≥1.0D of preoperative cylinder, preoperative mean refractive cylinder was 1.45±0.58D and 0.49D±0.41D postoperatively. Patients reported high satisfaction and NEI RQL-42 analyses demonstrated significant improvements in QOL at the 6-month visit compared to baseline.
Conclusions
This study demonstrated safety and effectiveness of EDOF ICLs to correct refractive error, with astigmatism (TEDOF) and presbyopia. Improvements in monocular UDVA, UIVA, and UNVA were reported for all treated eyes and no new risks of the EDOF ICL were identified. There are significant benefits of EDOF ICLs including improvement of quality of life.