A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01225926
• Collaborator: (none)
• Enrollment: 24
• Arms: 2
• Duration (Months): 15

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Toric T3 - T9; Device: IQ SN60WF	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Toric T3 - T9 AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.	Device: Toric T3 - T9; Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient; Other Names: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9
Active Comparator: IQ SN60WF AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.	Device: IQ SN60WF; Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient; Other Names: AcrySof® IQ IOL Model SN60WF

Outcome Measures

Primary Outcome Measures

1. Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 [Month 3]

   Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Willing and able to understand and sign an informed consent;

• Willing and able to attend post-operative examinations per protocol schedule;

• In good ocular health, with the exception of cataracts;

• Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;

• Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;

• In good ocular health, with the exception of cataracts;

• Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Previous corneal surgery;

• Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;

• Planned multiple procedures during cataract/IOL implantation surgery;

• Ocular disease and/or condition that may compromise study results;

• Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;

• Pregnant or planning pregnancy during course of study;

• Participation in any other investigational study within 30 days prior to enrolment;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01225926
• Other Study ID Numbers: M10-003
• First Posted: Oct 21, 2010
• Last Update Posted: Oct 29, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Alcon Research: Intraocular Lens; Toric
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from one study center located in Russia.

Arm/Group Title	Toric T3 - T9	IQ SN60WF
Arm/Group Description	AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.	AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
Period Title: Overall Study
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Toric T3 - T9	IQ SN60WF	Total
Arm/Group Description	AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.	AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.	Total of all reporting groups
Overall Participants	12	12	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.2 (18.64)	55.5 (16.52)	51.8 (17.63)
Sex: Female, Male (Count of Participants)
Female	7 58.3%	8 66.7%	15 62.5%
Male	5 41.7%	4 33.3%	9 37.5%

Outcome Measures

1. Primary Outcome

Title	Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3
Description	Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

Per protocol: All subjects who received IOLs in both eyes and followed the protocol with no major protocol deviations.

Arm/Group Title	Toric T3 - T9	IQ SN60WF
Arm/Group Description	AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.	AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
Measure Participants	11	12
Mean (Standard Deviation) [logMAR]	0.089 (0.1212)	0.225 (0.1503)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study. An adverse event was defined as any untoward medical occurrence in a subject regardless of whether or not the event had a causal relationship with the medical device under investigation.
Adverse Event Reporting Description	The safety population included all enrolled subjects who received at least one IOL and reported at least one safety assessment.
Arm/Group Title	Toric T3 - T9		IQ SN60WF
Arm/Group Description	AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.		AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
All Cause Mortality
	Toric T3 - T9		IQ SN60WF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Toric T3 - T9		IQ SN60WF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/12 (0%)
Eye disorders
IOL shift on 10-15 degrees	1/12 (8.3%)	1	0/12 (0%)	0
Other (Not Including Serious) Adverse Events
	Toric T3 - T9		IQ SN60WF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

This study was considered a pilot study and did not have an expectation to meet any of the study endpoints.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.