Trial Outcomes & Findings for A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation (NCT NCT01225926)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Month 3

Results posted on

2013-10-29

Participant Flow

Subjects were recruited from one study center located in Russia.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Toric T3 - T9 n=12 Participants 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.	IQ SN60WF n=12 Participants 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 n=24 Participants Total of all reporting groups
Age Continuous	48.2 years STANDARD_DEVIATION 18.64 • n=5 Participants	55.5 years STANDARD_DEVIATION 16.52 • n=7 Participants	51.8 years STANDARD_DEVIATION 17.63 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3

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

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.

Outcome measures

Outcome measures
Measure	Toric T3 - T9 n=11 Participants 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.	IQ SN60WF n=12 Participants 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.
Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3	0.089 logMAR Standard Deviation 0.1212	0.225 logMAR Standard Deviation 0.1503

Adverse Events

Toric T3 - T9

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

IQ SN60WF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Toric T3 - T9 n=12 participants at risk 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.	IQ SN60WF n=12 participants at risk 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.
Eye disorders IOL shift on 10-15 degrees	8.3% 1/12 • Number of events 1 • 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. The safety population included all enrolled subjects who received at least one IOL and reported at least one safety assessment.	0.00% 0/12 • 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. The safety population included all enrolled subjects who received at least one IOL and reported at least one safety assessment.

Other adverse events

Adverse event data not reported

Additional Information

Manoj Venkiteshwar, Brand Lead, Global Medical Affairs

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER