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Trial Outcomes & Findings for Correction of Farsightedness in Children Study (NCT NCT00472212)

NCT ID: NCT00472212

Last Updated: 2023-04-18

Results Overview

The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skill (reading comprehension). The K-TEA is a well-established, individually administered, standardized test for assessment of achievement in reading, with a mean standard score of 100 and standard deviation of 15. Higher values represent better performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

6 week outcome exam

Results posted on

2023-04-18

Participant Flow

Participant milestones

Participant milestones
Measure
Glasses With Hyperopic Lenses
Spectacles with hyperopic lenses Spectacles: Hyperopic spectacle lenses
Control
Spectacles with placebo lenses Control: Plano (no power, control) spectacle lenses
Overall Study
STARTED
31
27
Overall Study
COMPLETED
25
23
Overall Study
NOT COMPLETED
6
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Glasses With Hyperopic Lenses
Spectacles with hyperopic lenses Spectacles: Hyperopic spectacle lenses
Control
Spectacles with placebo lenses Control: Plano (no power, control) spectacle lenses
Overall Study
Lost to Follow-up
6
4

Baseline Characteristics

One subject with race /ethnicity not reported

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Glasses With Hyperopic Lenses
n=31 Participants
Spectacles with hyperopic lenses Spectacles: Hyperopic spectacle lenses
Control
n=27 Participants
Spectacles with placebo lenses Control: Plano (no power, control) spectacle lenses
Total
n=58 Participants
Total of all reporting groups
Age, Continuous
7.58 years
STANDARD_DEVIATION 1.78 • n=31 Participants
7.41 years
STANDARD_DEVIATION 1.47 • n=27 Participants
7.5 years
STANDARD_DEVIATION 1.64 • n=58 Participants
Sex: Female, Male
Female
17 Participants
n=31 Participants
13 Participants
n=27 Participants
30 Participants
n=58 Participants
Sex: Female, Male
Male
14 Participants
n=31 Participants
14 Participants
n=27 Participants
28 Participants
n=58 Participants
Race/Ethnicity, Customized
African American
18 Participants
n=30 Participants • One subject with race /ethnicity not reported
17 Participants
n=27 Participants • One subject with race /ethnicity not reported
35 Participants
n=57 Participants • One subject with race /ethnicity not reported
Race/Ethnicity, Customized
White
8 Participants
n=30 Participants • One subject with race /ethnicity not reported
9 Participants
n=27 Participants • One subject with race /ethnicity not reported
17 Participants
n=57 Participants • One subject with race /ethnicity not reported
Race/Ethnicity, Customized
Hispanic
4 Participants
n=30 Participants • One subject with race /ethnicity not reported
1 Participants
n=27 Participants • One subject with race /ethnicity not reported
5 Participants
n=57 Participants • One subject with race /ethnicity not reported
Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score
95.17 units on a scale (standard score)
STANDARD_DEVIATION 13.47 • n=29 Participants • Test results not available for two subjects.
97.07 units on a scale (standard score)
STANDARD_DEVIATION 13.38 • n=27 Participants • Test results not available for two subjects.
96.09 units on a scale (standard score)
STANDARD_DEVIATION 13.34 • n=56 Participants • Test results not available for two subjects.
Cognitive Assessment System (CAS) Attention Score
97.83 units on a scale (standard score)
STANDARD_DEVIATION 17.09 • n=29 Participants • Test results not available for 2 subjects.
101.96 units on a scale (standard score)
STANDARD_DEVIATION 19.52 • n=27 Participants • Test results not available for 2 subjects.
99.82 units on a scale (standard score)
STANDARD_DEVIATION 18.25 • n=56 Participants • Test results not available for 2 subjects.
Accommodative Response by monocular estimation method (MEM)
0.71 diopters
STANDARD_DEVIATION 0.42 • n=31 Participants
0.67 diopters
STANDARD_DEVIATION 0.45 • n=27 Participants
0.69 diopters
STANDARD_DEVIATION 0.43 • n=58 Participants

PRIMARY outcome

Timeframe: 6 week outcome exam

The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skill (reading comprehension). The K-TEA is a well-established, individually administered, standardized test for assessment of achievement in reading, with a mean standard score of 100 and standard deviation of 15. Higher values represent better performance.

Outcome measures

Outcome measures
Measure
Glasses With Hyperopic Lenses
n=24 Participants
Glasses with hyperopic lenses (Correction)
Control
n=23 Participants
Glasses with placebo lenses Control: Glasses with plano (no power, control) spectacle lenses
Change in Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
-2.92 score on a scale
Interval -7.9 to 2.1
0.088 score on a scale
Interval -5.0 to 5.2

SECONDARY outcome

Timeframe: 6 week outcome exam

Individually administered battery designed to measure cognitive processing abilities. CAS is based on PASS (Planning, Attention, Simultaneous, and Successive), a well-researched cognitive/neuropsychological theory. A higher score indicates a better outcome.

Outcome measures

Outcome measures
Measure
Glasses With Hyperopic Lenses
n=24 Participants
Glasses with hyperopic lenses (Correction)
Control
n=23 Participants
Glasses with placebo lenses Control: Glasses with plano (no power, control) spectacle lenses
Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
9.14 score on a scale
Interval 4.8 to 13.5
3.46 score on a scale
Interval -1.0 to 7.9

SECONDARY outcome

Timeframe: 6 week outcome exam

Accommodative response, Right eye. This is a measure the accuracy of focusing (accommodative accuracy or response) while the subject views a near target. Lower (positive) values represent better accuracy of focusing.

Outcome measures

Outcome measures
Measure
Glasses With Hyperopic Lenses
n=25 Participants
Glasses with hyperopic lenses (Correction)
Control
n=23 Participants
Glasses with placebo lenses Control: Glasses with plano (no power, control) spectacle lenses
Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
0.23 Diopters
Interval -0.068 to 0.53
0.054 Diopters
Interval -0.25 to 0.36

Adverse Events

Glasses With Hyperopic Lenses

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

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

Marjean Kulp

The Ohio State University College of Optometry

Phone: 614-688-3336

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place