Prospective Multicenter Evaluation of the Visual Performance of a Non-constant Aberration Correcting Aspheric Monofocal Intraocular Lens (Precise Study)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

• Be at least 50 years of age or older, male or female, of any race or ethnicity.

• Presenting for uncomplicated bilateral cataract surgery for age-related cataract.

• Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).

• Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D).

• Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage)

• No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20/25 or better in both eyes as estimated by potential acuity meter or surgeon estimation.

• Provide written informed consent and a signed HIPPA form.

• Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.

Locations
United States
Indiana
Price Vision Group
NOT_YET_RECRUITING
Indianapolis
Kentucky
Huffman & Huffman PSC
RECRUITING
Lexington
Pennsylvania
The Pennsylvania State University and Penn State Health
NOT_YET_RECRUITING
Hershey
Other Locations
Mexico
Asociación Para Evitar La Ceguera en México, I.A.P.
NOT_YET_RECRUITING
Mexico City
Contact Information
Primary
Grant Sharpe
grant.sharpe@zeiss.com
+447918937014
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2024-12
Participants
Target number of participants: 44
Treatments
Experimental: Bilateral implantation of investigational device
Monofocal IOL
Related Therapeutic Areas
Sponsors
Leads: Carl Zeiss Meditec AG

This content was sourced from clinicaltrials.gov