A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

NCT ID: NCT02223650

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to overminus by comparing treatment groups on the following outcomes:

• Mean distance IXT control score (each patient's score is the mean of 3 control scores) (primary outcome)
• The proportion of subjects with treatment response, defined as 1 or more points improvement in mean of 3 distance IXT control scores (secondary outcome)
• Adverse effects, near visual acuity outcomes, and spectacle wear compliance

Conditions

Intermittent Exotropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Overminus Treatment

2.50D overminus spectacles

Group Type: EXPERIMENTAL

Overminus treatment

Intervention Type: DEVICE

2.50D overminus spectacles

Non-overminus Treatment

spectacles without overminus or no spectacles

Group Type: ACTIVE_COMPARATOR

Non-overminus treatment

Intervention Type: DEVICE

spectacles without overminus or no spectacles

Interventions

Overminus treatment

2.50D overminus spectacles

Intervention Type: DEVICE

Non-overminus treatment

spectacles without overminus or no spectacles

Intervention Type: DEVICE

Other Intervention Names

Overminus spectacles; Overminus glasses; Overminus therapy

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Eye Disease Investigator Group

NETWORK

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan M Holmes, MD

Role: STUDY_CHAIR

Mayo Clinic

Angela M Chen, OD, MS

Role: STUDY_CHAIR

Marshall B. Ketchum University

Locations

Marshall B. Ketchum University

Fullerton, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27506485 (View on PubMed)

Related Links

http://pedig.jaeb.org

PEDIG Public Website

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IXT3

Identifier Type: -

Identifier Source: org_study_id