Overminus Lens Therapy in Intermittent

• Conditions: Intermittent Exotropia; Over-minus Therapy; Myopia Progression; Myopia Overcorrection

• Registration Number: NCT03952702
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-01-01
• Study First Submitted: 2019-04-30
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia.	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.	4 years	Changes in stereopsis values (arcsec) evaluated with TNO test were observed.
The long-term effect of prescribing overminus lenses on refractive changes.	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.

Trial Locations

Locations (1)

Ege University Faculty of Medicine; 🇹🇷 Izmir, Turkey