Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01200511
First received: September 10, 2010
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Cataract
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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 Outcome Measures:
  • 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.


Enrollment: 49
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReSTOR +3.0
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Other Name: Models SND1T3, SND1T4, SND1T5

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200511

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Brand Lead, Surgical, Global Medical Affairs Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01200511     History of Changes
Other Study ID Numbers: M09-052
Study First Received: September 10, 2010
Results First Received: January 13, 2017
Last Updated: March 9, 2017

Keywords provided by Alcon Research:
intraocular lens
multifocal
toric

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 25, 2017