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Under-correction in Refractive Accommodative Esotropia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179711
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Samsung Medical Center
  Purpose
In most clinics, physicians reduce diopter of hyperopic glasses in older patients with accommodative esotropia. However, there are risks of decompensation in that practice. The authors are going to try measure the change of stability of eye alignment after reducing diopter of hyperopic glasses.

Condition Intervention
Accommodative Esotropia Device: Glasses prescription

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Maximal Tolerable Reduction in Hyperopic Correction in Patients With Refractive Accommodative Esotropia: A 6-month Follow-up Study

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • eye alignment [ Time Frame: 6 months ]
    Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, symptoms such as asthenopia, diplopia, or blurred vision will be documented and ocular examinations including ocular alignment status for distance and near will be performed.


Secondary Outcome Measures:
  • stereopsis [ Time Frame: 6 months ]
    Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, tests of fusion and stereoacuity will be performed.


Enrollment: 41
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
glasses prescription
At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).
Device: Glasses prescription
At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).

Detailed Description:

Inclusion criteria :

patients with accommodative esotropia

At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).

Outcome measure :

Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, symptoms such as asthenopia, diplopia, or blurred vision will be documented and ocular examinations, including visual acuity and ocular alignment status for distance and near will be performed. Tests of fusion and stereoacuity will be performed at the 1-month, 3-month, and 6-month follow-up visits.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with accommodative esotropia
  • older than 24 months

Exclusion Criteria:

  • unstable eye alignment
  • older than 18 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179711


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Chair: Sei Yeul Oh, MD Samsung Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyung Ah Park, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01179711     History of Changes
Other Study ID Numbers: 2009-06-027
First Submitted: August 5, 2010
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
Last Verified: August 2010

Keywords provided by Samsung Medical Center:
accommodative esotropia

Additional relevant MeSH terms:
Esotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases