Visual Performance, Patient Satisfaction, and Quality of Vision Outcomes in Presbyopia-Correcting IOLs: A Prospective Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Study Goal The goal of this clinical trial is to compare how well four different types of artificial lenses (called intraocular lenses or IOLs) help people see after cataract surgery. The main questions it aims to answer are: Which lens gives the best vision at different distances (far, middle, and close)? How satisfied are patients with their vision after surgery? How often do patients still need glasses after surgery? Who Can Participate Adults aged 22 to 85 years who need cataract surgery in both eyes and meet specific health requirements. Study Design Researchers compared six different lens types: TECNIS Eyhance - designed to improve middle-distance vision AcrySof IQ Vivity - extends the range of clear vision LuxSmart - uses special optics for better depth of focus Rayner EMV - uses gradual light-bending technology for smooth vision transition Eycryl SERT - modifies light focus to extend clear vision range CT ASPHINA 409M - standard single-focus lens (comparison group) Participants chose their preferred lens type after learning about each option's benefits and limitations. What Participants Do? Participants will: Have cataract surgery on both eyes (1-2 weeks apart) Complete vision tests at multiple distances Take contrast sensitivity tests under different lighting conditions Fill out questionnaires about vision quality and daily activities Attend follow-up visits at 1 day, 1 week, 1 month, and 3 months This study helps patients and doctors make informed decisions about which type of artificial lens might work best for individual needs and lifestyle.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 85
Healthy Volunteers: f
View:

• Bilateral implantation of the same intraocular lens (IOL) model

• Expected postoperative best-corrected distance visual acuity (BCDVA) of 0.8 (decimal) or better

• Regular corneal astigmatism less than 1 diopter

Locations
Other Locations
Germany
Augenklinik Ahaus
RECRUITING
Ahaus
Contact Information
Primary
dr. med. (Univ. Bud.) Matthias Gerl, MD
m.gerl@augenklinik.de
+49 (2561) 9555-301
Backup
Matthias Müller, Dipl.-Ing.FH
M.Mueller@augenklinik.de
+49 (0)2561-9555-247
Time Frame
Start Date: 2022-04-12
Estimated Completion Date: 2026-01
Participants
Target number of participants: 180
Treatments
Experimental: CT ASPHINA 409M IOL group
The monofocal intraocular lens CT ASPHINA 409M (Carl Zeiss Meditec AG, Germany) will be implanted during catarct surgery
Experimental: TECNIS Eyhance ICB00 IOL group
The intraocular lens TECNIS Eyhance ICB00 (Johnson \& Johnson Surgical Vision, Irvine, CA, USA) will be implanted during catarct surgery
Experimental: AcrySof® IQ Vivity® IOL group
The intraocular lens AcrySof® IQ Vivity® (Alcon Laboratories, Fort Worth, TX, USA) will be implanted during catarct surgery
Experimental: LuxSmart™ IOL group
The intraocular lens LuxSmart™ (Bausch+Lomb, Rochester, NY, USA) will be implanted during catarct surgery
Experimental: Eyecryl SERT IOL group
The intraocular lens Eyecryl SERT (Biotech Healthcare Group, Luzern, Switzerland) will be implanted during catarct surgery
Experimental: RayOne EMV IOL group
The intraocular lens RayOne EMV (Rayner Intraocular Lenses Ltd.) will be implanted during catarct surgery
Related Therapeutic Areas
Sponsors
Leads: Augenklinik Ahaus G + H GmbH & Co. KG

This content was sourced from clinicaltrials.gov