Overminus Lens Therapy in Intermittent

• Sponsor: Ege University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03952702
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Anticipated Duration (Months): 28.9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Jun 1, 2019

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University Faculty of Medicine	Izmir		Turkey	35040

Sponsors and Collaborators

• Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elif Demirkilinc Biler, Assoc. Prof., M.D., Ege University
• ClinicalTrials.gov Identifier: NCT03952702
• Other Study ID Numbers: Ege30042919
• First Posted: May 16, 2019
• Last Update Posted: May 16, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elif Demirkilinc Biler, Assoc. Prof., M.D., Ege University: Intermittent exotropia; overminus lens therapy; myopic overcorrection
• Additional relevant MeSH terms: Exotropia; Myopia

Study Results

No Results Posted as of May 16, 2019