A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

NCT02223650 | Completed Results DMC

• 2 other identifiers: IXT32U10EY011751
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D) overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in children with intermittent exotropia (IXT) 3 to \<7 years of age is to determine whether to proceed to a full-scale, longer-term randomized trial.

Conditions

Intermittent Exotropia

Keywords

Intermittent Exotropia; IXT; overminus

Outcome Measures

Primary Outcomes (1)

• Mean Distance Exotropia Control Score

  At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score\* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. \*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.

  8 weeks

Secondary Outcomes (12)

• Mean Near Exotropia Control Score

  8 weeks

• Distribution of Distance Control Score at 8-week Outcome

  8 weeks

• Distribution of Near Control Score at 8-week Outcome

  8 weeks

• Proportion of Subjects With Distance Control Treatment Response

  8 weeks

• Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?

  8 weeks

Study Arms (2)

Overminus Treatment

EXPERIMENTAL

2.50D overminus spectacles

Device: Overminus treatment

Non-overminus Treatment

ACTIVE COMPARATOR

spectacles without overminus or no spectacles

Device: Non-overminus treatment

Interventions

Overminus treatment DEVICE

2.50D overminus spectacles

Also known as: Overminus spectacles, Overminus glasses, Overminus therapy

Overminus Treatment

Non-overminus treatment DEVICE

spectacles without overminus or no spectacles

Non-overminus Treatment

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

The following criteria must be met for the child to be enrolled in the study: * Age 3 years to \< 7 years * Intermittent exotropia (manifest deviation) meeting all of the following criteria: * Intermittent exotropia or constant exotropia at distance * Mean distance control score of 2 points or more (mean of 3 assessments over the exam) * Intermittent exotropia, exophoria, or orthophoria at near * Subject cannot have a score of 5 points on all 3 near assessments of control * Exodeviation at least 15∆ at distance measured by PACT * Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded) * No previous non-surgical treatment for IXT (other than refractive correction), including vision therapy for IXT, within the past 6 months. * No previous substantial overminus treatment, defined as wearing spectacles that are overminused by 1.00D SE or more (treatment with lenses overminused by less than 1.00D SE is allowed at any time prior to enrollment). * No vision therapy, patching, atropine, or other penalization for amblyopia during the last 2 weeks * No prior strabismus, intraocular, or refractive surgery (including BOTOX injection) * Cycloplegic refraction within 7 months, but NOT on the day of enrollment * Spherical equivalent (SE) in both eyes between -6.00D and +1.00D inclusive * Distance visual acuity 0.3 logMAR (20/40) or better (by ATS-HOTV) in both eyes * No interocular difference of distance visual acuity more than 0.2 logMAR (2 lines) * Child must be wearing refractive correction (pre-study spectacles) for at least 1 week if refractive error (based on cycloplegic refraction performed within 7 months) meets any of the following: * SE anisometropia ≥1.00 D * Astigmatism ≥1.00 D in either eye * SE myopia ≥-0.50 D in either eye * Refractive correction must meet the following criteria relative to the cycloplegic refraction: * SE anisometropia must be within \<1.0D of the SE anisometropic difference * Astigmatism must be within \<1.00D of full magnitude; axis must be within 10 degrees if ≤1.00D, and within 5 degrees if \>1.00D. * The SE of the spectacles must be within \<1.00D of the full cycloplegic refraction SE. * A correction that yields at least 1.00 D more minus SE than the cycloplegic refraction SE is considered previous substantial overminus lens treatment and the patient is not eligible. * No current contact lens wear * No abnormality of the cornea, lens, or central retina * Gestational age ≥ 32 weeks * Birth weight \> 1500 grams * No Down syndrome or cerebral palsy * No severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded. * No disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease * No current use of any ocular or systemic medication known to affect accommodation or vergence, such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics (e.g., motion sickness patch (scopolamine)), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil) * Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus status * Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff * Relocation outside of area of an active PEDIG site within next 8 weeks is not anticipated

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Pediatric Eye Disease Investigator Group: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (2)

Marshall B. Ketchum University

Fullerton, California, 92831, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Pediatric Eye Disease Investigator Group; Chen AM, Holmes JM, Chandler DL, Patel RA, Gray ME, Erzurum SA, Wallace DK, Kraker RT, Jensen AA. A Randomized Trial Evaluating Short-term Effectiveness of Overminus Lenses in Children 3 to 6 Years of Age with Intermittent Exotropia. Ophthalmology. 2016 Oct;123(10):2127-36. doi: 10.1016/j.ophtha.2016.06.042. Epub 2016 Aug 6.

  PMID: 27506485 RESULT

Related Links

• PEDIG Public Website

Limitations and Caveats

Small sample size; only 8-weeks of follow up; high test-retest variability of control; some regression to the mean may be present; do not know if treatment effect would persist after overminus lenses are replaced with usual spectacle correction.

Results Point of Contact

• Title: Ray Kraker, M.S.P.H., Director of PEDIG Coordinating Center
• Organization: Jaeb Center for Health Research

rkraker@jaeb.org

(813) 975-8690

Study Officials

• Jonathan M Holmes, MD

  Mayo Clinic

  STUDY CHAIR

• Angela M Chen, OD, MS

  Marshall B. Ketchum University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 22, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 19, 2017
• Results First Posted: December 20, 2016

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)