| Title: |
Prospective, Randomized, Controlled Multicenter Study of a Monofocal Extended Depth of Focus IOL Compared to a Standard Aspheric Monofocal IOL |
| Authors: |
Packer, Mark; Monteiro, Tiago; Schweitzer, Cedric; Rosen, Paul |
| Contributors: |
Bordeaux population health (BPH); Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| Source: |
ISSN: 0886-3350. |
| Publisher Information: |
CCSD; Elsevier |
| Publication Year: |
2025 |
| Collection: |
Inserm: HAL (Institut national de la santé et de la recherche médicale) |
| Subject Terms: |
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie |
| Description: |
International audience ; PURPOSE: Investigate safety and effectiveness of a monofocal enhanced depth of focus intraocular lens (mono-EDoF IOL, xactTM Mono-EDoFTM Model ME4) compared to an aspheric monofocal IOL (TECNIS 1-Piece IOL Model ZCB00). SETTING: Sites in United Kingdom, France, and Portugal. DESIGN: Prospective, multicenter, controlled, single-masked, randomized 2:1 (test:control) clinical trial. METHODS: Adults ≥40 years of age with bilateral cataracts, expected post-operative refractive astigmatism of ≤1.0D and calculated lens power 18D to 30D underwent implantation of either mono-EDoF or aspheric monofocal IOL in both eyes. Primary endpoints assessed at day 120-180 included monocular uncorrected distance visual acuity (UDVA) and visual disturbances. Secondary endpoints were monocular uncorrected intermediate visual acuity (UIVA) and monocular distance corrected intermediate visual acuity (DCIVA). RESULTS: Sixty-five patients were randomized; 45 patients (95.2%) with Mono-EDoF and 20 patients (95.2%) with control completed the study. Compared with control, Mono-EDoF had significantly better monocular UDVA (P=0.0128), monocular UIVA (P |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1097/j.jcrs.0000000000001672 |
| Availability: |
https://hal.science/hal-05086348; https://hal.science/hal-05086348v1/document; https://hal.science/hal-05086348v1/file/BPH_JCRS_2025_Packer.pdf; https://doi.org/10.1097/j.jcrs.0000000000001672 |
| Rights: |
https://creativecommons.org/licenses/by-nc-nd/4.0/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.44B6046C |
| Database: |
BASE |