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Completed

NCT Number: NCT01200511

Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign informed consent;
  • Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
  • Able to undergo second eye surgery within one month (30 days) of first eye surgery;
  • Able to attend postoperative examinations per protocol schedule;
  • Qualify for a AcrySof IQ Toric IOL in both eyes;
  • Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
  • Residual refractive cylinder of ≤0.5 D in both eyes;
  • Good ocular health;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
  • Amblyopia;
  • Previous corneal surgery;
  • Clinically significant corneal endothelial dystrophy;
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
  • History of retinal detachment;
  • Pregnant or planning to become pregnant during course of study;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Device

Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Other names: Models SND1T3, SND1T4, SND1T5

Primary outcomes

  1. Uncorrected Visual Acuity Across a Range of Distances at Month 6

    Time frame: Month 6 from second eye implantation

    Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. 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.

  2. Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6

    Time frame: Month 6 from second eye implantation

    VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. 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.

  3. Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6

    Time frame: Month 6 from second eye implantation

    Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.

Secondary outcomes

  1. Patient Reported Outcomes at Month 6

    Time frame: Month 6 from second eye implantation

    The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2010
Registry last updated
Jul 2, 2018

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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