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Completed

NCT Number: NCT02691741

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

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

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Device

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

Other names: Model TFNT00

AT LISA® tri IOL

Device

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

Other names: Model 839MP

Primary outcomes

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

    Time frame: Day 120-180 from second eye implantation

    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.

Secondary outcomes

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

    Time frame: Day 120-180 from second eye implantation

    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in 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.

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

    Time frame: Day 120-180 from second eye implantation

    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in 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.

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

    Time frame: Day 120-180 from second eye implantation

    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in 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.

  4. Mean Photopic Binocular Defocus Curve at Day 120-180

    Time frame: Day 120-180 from second eye implantation

    A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.

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

    Time frame: Day 120-180 from second eye implantation

    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

  6. Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180

    Time frame: Day 120-180 from second eye implantation

    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

  7. Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180

    Time frame: Day 120-180 from second eye implantation

    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

  8. Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180

    Time frame: Day 120-180 from second eye implantation

    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

  9. Subject Satisfaction Recorded at Day 120-180

    Time frame: Day 120-180 from second eye implantation

    At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2016
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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