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A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01257217
First received: December 8, 2010
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

Condition Intervention
Cataract Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT Device: Acri.LISA® 366D IOL Device: Acri.LISA® 466TD Toric IOL

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Binocular Defocus VA at Month 3 [ Time Frame: Month 3 from second eye implantation ]
    Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power 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 Outcome Measures:
  • Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3 [ Time Frame: Month 3 from second eye implantation ]
    Visual acuity (VA) was tested binocularly (both eyes together) 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.

  • Uncorrected Visual Acuity Across a Range of Distances at Month 3 [ Time Frame: Month 3 from second eye implantation ]
    VA was tested binocularly 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.

  • Mean Refractive Spherical Equivalent at Month 3 [ Time Frame: Month 3 from second eye implantation ]
    A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.

  • Mean Radner Reading Speed [ Time Frame: Month 3 from second eye implantation ]
    Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.

  • Patient Reported Outcomes at Month 3 [ Time Frame: Month 3 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. Tasks were rated 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: 31
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReSTOR +3
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
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 SND1T2, SND1T3, SND1T4, SND1T5, SND1T6
Active Comparator: Acri.LISA
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Device: Acri.LISA® 366D IOL
Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient
Device: Acri.LISA® 466TD Toric IOL
Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Detailed Description:
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.
  Eligibility

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

Inclusion Criteria:

  • Sign informed consent;
  • Able to attend postoperative examinations per protocol schedule;
  • Diagnosed with bilateral cataracts;
  • Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
  • Preoperative astigmatism ≤ 2.5 diopter;
  • Good ocular health, with the exception of cataracts;
  • Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
  • Able to undergo second eye surgery within one month of the first eye surgery;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Previous corneal surgery;
  • Planned multiple procedures during cataract/IOL implantation surgery;
  • Any ocular disease and/or condition that may compromise study results;
  • Pregnant or planning pregnancy during course of study;
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
  • Diabetic retinopathy;
  • Macular degeneration;
  • History of retinal detachment;
  • 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: NCT01257217

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: NCT01257217     History of Changes
Other Study ID Numbers: M09-051
Study First Received: December 8, 2010
Results First Received: January 13, 2017
Last Updated: March 9, 2017

Keywords provided by Alcon Research:
Intraocular Lens
Presbyopia
multifocal

Additional relevant MeSH terms:
Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on August 22, 2017