NCT01424189

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
677

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed
Last Updated

June 29, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

August 25, 2011

Results QC Date

January 13, 2017

Last Update Submit

May 31, 2018

Conditions

Cataracts

Keywords

Cataract surgeryIntraocular lens

Outcome Measures

Primary Outcomes (3)

  • Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5

    Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

    Month 12 from second eye implantation

  • Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5

    VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. 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. This analysis was prespecified for the first operative eye.

    Month 12 from second eye implantation

  • Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5

    The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.

    Month 12 from second eye implantation

Secondary Outcomes (1)

  • Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5

    Month 12 from second eye implantation

Study Arms (2)

ReSTOR Toric IOL

EXPERIMENTAL

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

ReSTOR IOL

ACTIVE COMPARATOR

AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation

Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3

Interventions

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOLDEVICE

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

Also known as: Models SND1T3, SND1T4, SND1T5, SND1T6
ReSTOR Toric IOL
AcrySof® ReSTOR® Multifocal IOL Model SA60D3DEVICE

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

ReSTOR IOL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with bilateral cataracts;
  • Able to comprehend and sign a statement of informed consent;
  • Calculated lens power and astigmatism within the available range;
  • Willing and able to complete all required postoperative visits;
  • Planned cataract removal by phacoemulsification;
  • Potential postoperative visual acuity of 0.2 logMAR or better in both eyes;
  • Preoperative astigmatism in both operative eyes as described in the clinical protocol; Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.
  • Clear intraocular media other than cataract in study eyes;
  • Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR in each eye;
  • Pupil size greater than or equal to 6 mm after dilation;
  • Able to undergo second eye surgery within 30 days of the first eye surgery;

You may not qualify if:

  • Significant irregular corneal aberration as demonstrated by corneal topography;
  • Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism;
  • Any inflammation or edema (swelling) of the cornea;
  • Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.2 logMAR;
  • Reasonably expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy);
  • Previous corneal refractive surgery;
  • Amblyopia;
  • Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
  • Diabetic retinopathy;
  • Extremely shallow anterior chamber, not due to swollen cataract;
  • Microphthalmos;
  • Previous retinal detachment;
  • Previous corneal transplant;
  • Recurrent severe anterior or posterior segment inflammation of unknown etiology;
  • Rubella or traumatic cataract;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Williams JR, Kim HW, Crespi CM. Modeling observations with a detection limit using a truncated normal distribution with censoring. BMC Med Res Methodol. 2020 Jun 29;20(1):170. doi: 10.1186/s12874-020-01032-9.

    PMID: 32600261DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Expert Clinical Project Lead, GCRA, Surgical
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Expert Clinical Project Lead, GCRA, Surgical

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2011

First Posted

August 26, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 29, 2018

Results First Posted

March 6, 2017

Record last verified: 2018-05