Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)

Alcon logo

Alcon

Status

Completed

Conditions

Cataracts

Treatments

Device: AT LISA® tri IOL
Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02691741
ILH297-P003

Details and patient eligibility

About

The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.

Full description

Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.

Enrollment

215 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
  • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
  • Calculated lens power between 13.0 and 30.0 Diopters (D);
  • Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
  • Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
  • Preoperative regular corneal astigmatism of < 1.00 D, in both eyes;
  • Clear intraocular media other than cataract in both eyes;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
  • Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
  • Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
  • Amblyopia;
  • Previous corneal transplant;
  • Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction;
  • Rubella, congenital, traumatic, or complicated cataracts;
  • Glaucoma (uncontrolled or controlled with medication);
  • Degenerative eye disorders;
  • History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy;
  • Optic nerve atrophy;
  • Expected to require retinal laser treatment;
  • Color vision deficiencies;
  • Pregnant or lactating (current or planned during the course of the study);
  • Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

215 participants in 2 patient groups

TFNT00
Experimental group
Description:
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Treatment:
Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
839MP
Active Comparator group
Description:
AT LISA® tri IOL, bilateral implantation
Treatment:
Device: AT LISA® tri IOL

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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