HyperopiaCHICSNCT00472212

Correction of Farsightedness in Children Study

A study testing Spectacles in people with Hyperopia and Farsightedness, run by Ohio State University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, attention, and reading skills in children. Read more about this study

Who is it for?: Ages 6 to 11 yearsHealthy volunteers can take part
Conditions the study is for: Hyperopia, Farsightedness
What is being tested?: Spectacles
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 4 sitesUnited States
Study dates: Nov 2003to Mar 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age 6-11 years;
At least +1.00D Hyperopia (farsightedness);
< +4.00D Hyperopia;
< 1.00D Astigmatism;
< 1.00D Anisometropia (difference between the two eyes);
Willing to be randomized;

Show all 9Show fewer

Best corrected visual acuity of 20/25 or better in each eye;
Willing to wear eyeglasses full-time;
Willing to return for follow-up visits

Who cannot join

Previous wear of glasses or contacts for farsightedness/hyperopia;
Eye disease that affects visual function;
Amblyopia (lazy eye);
Strabismus (eye turn);
History of strabismus surgery;
Chronic use of any of the following medications:

Show all 13Show fewer

Antianxiety agents (Librium, Valium)
Antiarrythmic agents (Cifenline, Cibenzoline)
Anticholinergics (Motion sickness patch - scopolamine)
Bladder spasmolytic (Propiverine)
Chloroquine
Phenothiazines (Compazine, Mellaril, Thorazine)
Tricyclic antidepressants (Elavil, Nortriptyline, Tofranil)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Illinois College of Optometry/Illinois Eye Institute
Chicago, Illinois, 60616
The Ohio State University
Columbus, Ohio, 43210
Southern College of Optometry
Memphis, Tennessee, 38104
SUNY College of Optometry/University Optometric Center
New York, New York, 10036

Other trials in United States

About this study

Official title: Correction of Hyperopia in Children Study

Read the detailed description

Hyperopia (farsightedness) has been reported to be associated with reduced visual perceptual and reading abilities. However, there is controversy regarding whether or not to prescribe for low to moderate amounts of hyperopia. The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, attention, and reading skills in children.

Conditions: Hyperopia, Farsightedness
Being tested: Spectacles, Control
Medical subject headings: Hyperopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SpectaclesDevice
Hyperopic spectacle lenses
ControlDevice
Plano (no power, control) spectacle lenses

Study groups in NCT00472212
Study group	Role	What they receive
Spectacles	Experimental	Spectacles with hyperopic lenses Receives: Device: Spectacles
Control	Placebo comparator	Spectacles with placebo lenses Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
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.
Measured: 6 week outcome exam

Secondary outcomes (2)

Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
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.
Measured: 6 week outcome exam
Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
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.
Measured: 6 week outcome exam

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Mar 2008

First posted11 May 2007 (estimated)
Study startNov 2003
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperopiaStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00472212
Sponsor's protocol ID: 2001H0401
Acronym: CHICS
Status last verified: Mar 2023
First submitted: 9 May 2007
Last updated: 18 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
The Emmetropization Via Accommodation (EVA) - II Study
Hyperopia, Farsightedness
Recruiting
Eye Imaging for the Study of Childhood Myopia
Hyperopia and Myopia
Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Myopia, Refractive Errors

All Hyperopia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correction of Hyperopia in Children Study
ClinicalTrials.gov ID: NCT00472212
Acronym / sponsor ID: CHICS / 2001H0401
Conditions: Hyperopia, Farsightedness
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Collaborators: American Academy of Optometry, Transitions, Ohio Lions Eye Research Foundation, College of Optometrists in Vision Development, SUNY Research Foundation
Study start: Nov 2003
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 11 May 2007 (estimated)
Results: Posted 29 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Spectacles	Experimental	Device: SpectaclesSpectacles with hyperopic lenses
Control	Placebo comparator	Device: ControlSpectacles with placebo lenses

Who may qualify

Ages: 6 to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (9 listed)

Age 6-11 years;
At least +1.00D Hyperopia (farsightedness);
< +4.00D Hyperopia;
< 1.00D Astigmatism;
< 1.00D Anisometropia (difference between the two eyes);

Key exclusion criteria (13 listed)

Previous wear of glasses or contacts for farsightedness/hyperopia;
Eye disease that affects visual function;
Amblyopia (lazy eye);
Strabismus (eye turn);
History of strabismus surgery;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SpectaclesHyperopic spectacle lenses	Device	Spectacles
ControlPlano (no power, control) spectacle lenses	Device	Control

Primary outcome

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)
Time frame: 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.

2 secondary outcomes

Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
Time frame: 6 week outcome exam
Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
Time frame: 6 week outcome exam

Results and safety

Results posted to the registry on 29 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glasses With Hyperopic Lenses	31	25
Control	27	23

Primary outcome: 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)

Time frame: 6 week outcome exam. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Glasses With Hyperopic Lenses n = 24	Control n = 23
Value	-2.92 (-7.9 to 2.1)	0.088 (-5.0 to 5.2)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glasses With Hyperopic Lenses	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Control	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperopia

Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
The Emmetropization Via Accommodation (EVA) - II Study
Hyperopia, Farsightedness
Recruiting
Eye Imaging for the Study of Childhood Myopia
Hyperopia and Myopia
Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Myopia, Refractive Errors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marjean Kulp, OD principal investigator

Ohio State University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spectacles in people with Hyperopia and Farsightedness, run by Ohio State University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 6 week outcome exam). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00472212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.