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

NCT02691741 | Completed Results FDA Device

• 1 other identifier: ILH297-P003
• Study Type: interventional
• Target: 215
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

• Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180

  VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

  Day 120-180 from second eye implantation

Secondary Outcomes (9)

• Least Squares Mean Binocular UCIVA (60cm) at Day 120-180

  Day 120-180 from second eye implantation

• Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180

  Day 120-180 from second eye implantation

• Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180

  Day 120-180 from second eye implantation

• Mean Photopic Binocular Defocus Curve at Day 120-180

  Day 120-180 from second eye implantation

• Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180

  Day 120-180 from second eye implantation

Study Arms (2)

TFNT00

EXPERIMENTAL

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

839MP

ACTIVE COMPARATOR

AT LISA® tri IOL, bilateral implantation

Device: AT LISA® tri IOL

Interventions

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL DEVICE

Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Also known as: Model TFNT00

TFNT00

AT LISA® tri IOL DEVICE

Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Also known as: Model 839MP

839MP

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Global Brand Medical Affairs Lead, CDMA Surgical
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Manager, GCRA

  Alcon, a Novartis Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: April 29, 2016
• Primary Completion: July 17, 2017
• Study Completion: July 17, 2017
• Last Updated: September 27, 2019
• Results First Posted: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share