Trial Outcomes & Findings for Accommodation Disorders (NCT NCT01329848)

Results Overview

Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.

Recruitment status

COMPLETED

Target enrollment

83 participants

Primary outcome timeframe

3 week period

Results posted on

2015-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Discomfort Symptoms levels of discomfort while performing near work
Overall Study STARTED	83
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accommodation Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Discomfort Symptoms n=83 Participants level of discomfort symptoms while performing near work
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	83 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	83 participants n=5 Participants
Conlon Symptom Score	24.4 units on a scale STANDARD_DEVIATION 9.4 • n=5 Participants

PRIMARY outcome

Timeframe: 3 week period

Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.

Outcome measures

Outcome measures
Measure	Discomfort Symptoms n=54 Participants level of discomfort symptoms while performing near work
Accommodation Lag 5D	0.9 diopters Standard Deviation 0.6

SECONDARY outcome

Timeframe: 3 weeks

Measures visual discomfort symptoms while doing near work. 23 item survey using a 4-point rating scale (never, occasionally, often, almost always). Total raw score reported on a range from 0 to 69 with higher scores indicating more frequent symptoms.

Outcome measures

Outcome measures
Measure	Discomfort Symptoms n=54 Participants level of discomfort symptoms while performing near work
Conlon Symptom Survey	18.6 units on a scale Standard Deviation 12.7

Adverse Events

Changes in Visual Discomfort From Baseline

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

Dr. Chris Chase

Western University of Health Sciences

Phone: 909 706-3882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place