Trial Outcomes & Findings for Assessment of Visual Performance in Patients With Low Levels of Astigmatism (NCT NCT00842231)

Last Updated: 2010-09-28

Results Overview

Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision).

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

Day of study visit

Results posted on

2010-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Visual Performance Measures Collection of visual performance measures in subjects with low levels of astigmatism.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Visual Performance in Patients With Low Levels of Astigmatism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Visual Performance Measures n=40 Participants Collection of visual performance measures in subjects with low levels of astigmatism.
Age, Customized	40 Participants n=93 Participants
Sex: Female, Male Female	24 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day of study visit

Population: Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.

Outcome measures

Outcome measures
Measure	Visual Performance Measures n=40 Participants Collection of visual performance measures in subjects with low levels of astigmatism.
High and Low Contrast Acuity 9% Contrast Acuity	0.0855 logMAR Standard Deviation 0.1111
High and Low Contrast Acuity 25% Contrast Acuity	0.065 logMAR Standard Deviation 0.1019
High and Low Contrast Acuity 100% Contrast Acuity	0.082 logMAR Standard Deviation 0.1013

PRIMARY outcome

Timeframe: Day of Study Visit

Population: Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.

Contrast Sensitivity (CS) differences between subjects tested with full correction \& spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) \& mesopic conditions (with \& without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS.

Outcome measures

Outcome measures
Measure	Visual Performance Measures n=40 Participants Collection of visual performance measures in subjects with low levels of astigmatism.
Contrast Sensitivity Mesopic 3 cycles per degree (cpd)	-0.047 Logrithmic Units Standard Deviation 0.2917
Contrast Sensitivity Mesopic 6 cpd	0.0896 Logrithmic Units Standard Deviation 0.3575
Contrast Sensitivity Mesopic 9 cpd	0.0038 Logrithmic Units Standard Deviation 0.3597
Contrast Sensitivity Mesopic 12 cpd	-0.009 Logrithmic Units Standard Deviation 0.371
Contrast Sensitivity Mesopic with glare 3 cpd	0.0176 Logrithmic Units Standard Deviation 0.2271
Contrast Sensitivity Mesopic with glare 6 cpd	0.0241 Logrithmic Units Standard Deviation 0.3146
Contrast Sensitivity Mesopic with glare 9 cpd	0.0183 Logrithmic Units Standard Deviation 0.2728
Contrast Sensitivity Mesopic with glare 12 cpd	0.0669 Logrithmic Units Standard Deviation 0.2559
Contrast Sensitivity Photopic 3 cpd	0.0163 Logrithmic Units Standard Deviation 0.2257
Contrast Sensitivity Photopic 6 cpd	0.0181 Logrithmic Units Standard Deviation 0.2539
Contrast Sensitivity Photopic 9 cpd	0.0479 Logrithmic Units Standard Deviation 0.3866
Contrast Sensitivity Photopic 12 cpd	0.0321 Logrithmic Units Standard Deviation 0.3215

PRIMARY outcome

Timeframe: Day of Study Visit

Population: Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.

Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD).

Outcome measures

Outcome measures
Measure	Visual Performance Measures n=40 Participants Collection of visual performance measures in subjects with low levels of astigmatism.
Reading Acuity and Speed logRAD Line -0.1	2.7469 words per minute Interval -33.4577 to 38.9515
Reading Acuity and Speed logRAD Line 0	7.3292 words per minute Interval -10.7731 to 25.4315
Reading Acuity and Speed logRAD Line 0.1	11.7498 words per minute Interval -0.7918 to 24.2914
Reading Acuity and Speed logRAD Line 0.2	17.5404 words per minute Interval 6.6243 to 28.4565
Reading Acuity and Speed logRAD Line 0.3	10.1643 words per minute Interval -0.4353 to 20.7639
Reading Acuity and Speed logRAD Line 0.4	13.4166 words per minute Interval 3.244 to 23.5892
Reading Acuity and Speed logRAD Line 0.5	12.7487 words per minute Interval 2.5761 to 22.9213
Reading Acuity and Speed logRAD Line 0.6	11.9005 words per minute Interval 1.8592 to 21.9419
Reading Acuity and Speed logRAD Line 0.7	15.1714 words per minute Interval 5.1301 to 25.2127
Reading Acuity and Speed logRAD Line 0.8	9.7203 words per minute Interval -0.4523 to 19.8929
Reading Acuity and Speed logRAD Line 0.9	11.4863 words per minute Interval 1.3137 to 21.6589
Reading Acuity and Speed logRAD Line 1.1	16.4043 words per minute Interval 6.2317 to 26.5769
Reading Acuity and Speed logRAD Line 1.2	8.8952 words per minute Interval -1.2774 to 19.0679

Adverse Events

Visual Performance Measures

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No paper that incorporates Sponsor confidential information will be submitted for publication without Sponsor's prior written agreement.
Publication restrictions are in place

Restriction type: OTHER