Overminus Lens Therapy in Intermittent

NCT03952702 | Unknown DMC

• 1 other identifier: Ege30042919
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Exotropia; Myopia Overcorrection; Over-minus Therapy; Myopia Progression

Keywords

Intermittent exotropia; overminus lens therapy; myopic overcorrection

Outcome Measures

Primary Outcomes (3)

• The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia.

  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.

  4 years

• The long-term effect of overminus lenses on stereopsis of patients with intermittent exotropia.

  Changes in stereopsis values (arcsec) evaluated with TNO test were observed.

  4 years

• The long-term effect of prescribing overminus lenses on refractive changes.

  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.

  4 years

Interventions

Myopic overcorrection PROCEDURE

Myopic overcorrection

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive pediatric patients diagnosed with IXT and prescribed overminus lenses

You may qualify if:

• patients diagnosed with IXT
• prescribed overminus lenses

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine

Izmir, 35040, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., M.D.

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 16, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)