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Overminus Lens Therapy in Intermittent

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ClinicalTrials.gov Identifier: NCT03952702
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Elif Demirkilinc Biler, Ege University

Brief Summary:
In this prospective study, entitled "The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (IXT), treatment effect after overminus treatment has been discontinued and also investigated if overminus lenses cause myopia in long-term.

Condition or disease Intervention/treatment
Intermittent Exotropia Myopia Overcorrection Over-minus Therapy Myopia Progression Procedure: Myopic overcorrection

Detailed Description:

Purpose: To evaluate the long-term impact of overminus lenses in intermittent exotropia (IXT), to determine if the treatment effect would persist after overminus minus lenses are discontinued and also to investigate if overminus lenses cause myopia.

Materials and Method: Sixty-five consecutive cases of IXT followed for at least 48 months were included. Patients with a history of previous surgery, ocular pathology, convergence insufficiency, severe myopia (>-5.0 D), severe hyperopia (>+5.0 D), moderate or severe amblyopia and poor compliance with spectacles were excluded. Data was collected including near stereoacuity, AC/A ratio, control of IXT measured with Newcastle Control Score (NCS) at baseline and in all follow-up visits. Baseline values without overminus threapy were compared with postintervention values at every visit.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Myopic overcorrection
    Myopic overcorrection


Primary Outcome Measures :
  1. The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia. [ Time Frame: 4 years ]
    Overminus lenses were prescribed on the treatment of intermittent exotropia as the first choice. To investigate the effect of overminus lenses on treatment, progress in fusional capability of the patients evaluated with Newcastle control score system were investigated.

  2. The long-term effect of overminus lenses on stereopsis of patients with intermittent exotropia. [ Time Frame: 4 years ]
    Changes in stereopsis values (arcsec) evaluated with TNO test were observed.

  3. The long-term effect of prescribing overminus lenses on refractive changes. [ Time Frame: 4 years ]
    Refractive data of the patients in terms of dioptri were measured with autorefractometer during the long-term follow-up period to observe presence of any myopic shift.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive pediatric patients diagnosed with IXT and prescribed overminus lenses
Criteria

Inclusion Criteria:

  • patients diagnosed with IXT
  • prescribed overminus lenses

Exclusion Criteria:

  • a history of previous surgery, ocular pathology
  • convergence insufficiency type IXT
  • presence of any type of ocular deviation except IXT
  • presence of severe myopia (greater than -5.0 D)
  • presence of severe hyperopia (greater than +5.0 D)
  • presence of moderate or severe amblyopia
  • poor compliance with overminus spectacles
  • follow up period of <48 months after intervention.

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): NCT03952702


Locations
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Turkey
Ege University Faculty of Medicine
Izmir, Turkey, 35040
Sponsors and Collaborators
Ege University

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Responsible Party: Elif Demirkilinc Biler, Assoc. Prof., M.D., Ege University
ClinicalTrials.gov Identifier: NCT03952702     History of Changes
Other Study ID Numbers: Ege30042919
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elif Demirkilinc Biler, Ege University:
Intermittent exotropia
overminus lens therapy
myopic overcorrection

Additional relevant MeSH terms:
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Myopia
Exotropia
Refractive Errors
Eye Diseases
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases