Overminus Lens Therapy in Intermittent

Intermittent Exotropia Clinical Trial

Official title:

The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952702
• Other study ID #: Ege30042919
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: May 2019
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: June 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Myopic overcorrection
Myopic overcorrection

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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