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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

Tracking Information
First Submitted Date April 30, 2019
First Posted Date May 16, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Overminus Lens Therapy in Intermittent
Official Title The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All consecutive pediatric patients diagnosed with IXT and prescribed overminus lenses
Condition
  • Intermittent Exotropia
  • Myopia Overcorrection
  • Over-minus Therapy
  • Myopia Progression
Intervention Procedure: Myopic overcorrection
Myopic overcorrection
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 14, 2019)
65
Original Actual Enrollment Same as current
Estimated Study Completion Date June 1, 2019
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03952702
Other Study ID Numbers Ege30042919
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Elif Demirkilinc Biler, Ege University
Study Sponsor Ege University
Collaborators Not Provided
Investigators Not Provided
PRS Account Ege University
Verification Date May 2019