Evaluation of a Monofocal Intraocular Lens

Last updated: June 19, 2024
Sponsor: Carl Zeiss Meditec AG
Overall Status: Active - Recruiting

Phase

4

Condition

Eye Disease

Eye Disorders/infections

Vision Loss

Treatment

CT LUCIA 621P

Clinical Study ID

NCT06428955
GPAS-SAS-023-01
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

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

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

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

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

  6. No visual acuity limiting pathologies other than cataract. Best correctedpostoperative visual acuity potential of 20/25 or better in both eyes as estimatedby potential acuity meter or surgeon estimation.

  7. Provide written informed consent and a signed HIPPA form.

  8. Availability, willingness, ability, and sufficient cognitive awareness to complywith study examination procedures and the schedule for study visits and evaluations.

Exclusion

Exclusion Criteria:

  1. Corneal Astigmatism of >1.0 D.

  2. Planned monocular cataract extraction.

  3. Visual field loss which has an impact on visual acuity.

  4. Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOLcannot be implanted.

  5. History of acute or chronic disease, pathology, illness, or ocular trauma thatwould, in the surgeon's opinion, confound results (e.g., corneal pathology,keratoconus, strabismus, uncontrolled glaucoma)

  6. History of Glaucoma, macular degeneration, cystoid macular edema, proliferativediabetic retinopathy, amblyopia, etc.

  7. Previous intraocular or corneal surgery, including all forms of refractive surgerythat might confound the outcome of the investigation or increase the risk to thesubject

  8. Previous anterior or posterior chamber surgery other than peripheral retinal barrierlaser, SLT/ALT (e.g., vitrectomy, laser iridotomy)

  9. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupilsthat do not dilate under mesopic/scotopic conditions).

  10. Capsular or zonular abnormalities or other conditions that increase the risk ofzonular rupture during cataract extraction procedure and/or may affect thepostoperative centration or tilt of the lens

  11. Use of a systemic or ocular medication that might affect vision and confound theoutcome or increase the risk to the subject in the opinion of the investigator suchas tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)

  12. Cycloplegic pupil diameter <6.0 mm or the presence of ocular implants that limitpupil diameter (malyugin rings; iris prosthesis).

  13. Usage of contact lenses during study participation

  14. Pregnant, lactating during the course of the investigation, or has another conditionwith associated fluctuation of hormones that could lead to refractive changes

  15. Presence or history or any other condition or finding that, in the investigator'sopinion, makes the subject unsuitable as a candidate for study participation, mayincrease the operative risk or may confound the outcome of the study.

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: CT LUCIA 621P
Phase: 4
Study Start date:
June 06, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Asociación Para Evitar La Ceguera en México, I.A.P.

    Ciudad de México, Alcaldia Coyoacan C.P. 04030
    Mexico

    Site Not Available

  • Price Vision Group

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Huffman & Huffman PSC

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • The Pennsylvania State University and Penn State Health

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

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