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Effect of Peripheral Defocus on Axial Growth in Hyperopes

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ClinicalTrials.gov Identifier: NCT02686879
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : July 7, 2016
Sponsor:
Collaborator:
College of Optometrists
Information provided by (Responsible Party):
Aston University

Brief Summary:

Hyperopia, also known as farsightedness, is a common type of refractive error where distant objects may be seen more clearly than objects that are near.

Hyperopia is a known risk factor for amblyopia, (lazy eye), which may occur as a result of a squint (turn), or due to different levels of hyperopia between each eye (anisohyperopia).

Hyperopia and anisohyperopia often persist into adulthood resulting in impairment to binocular vision. Current management involves prescribing spectacles or contact lenses to correct the hyperopia in each eye, usually as a lifelong intervention.

In recent years there has been a great deal of interest in delaying progression of myopia (short-sightedness) by slowing down the growth of the eye using a particular type of contact lens termed a centre-distance multifocal design. There have been some encouraging results in this area to date.

The proposed study here would explore the use of centre-near multifocal design contact lenses to encourage growth of the eye, thereby reducing hyperopia. There are three elements to the programme of research:

  1. The natural progression of axial growth and refractive error will be measured in hyperopic and anisohyperopic subjects aged between 5 and 19. In other words, the natural growth of the eye will be followed without any intervention
  2. As a paired eye control study anisohyperopes aged between 8 and 15 will be fitted with a centre-near multifocal design contact lens in their more hyperopic eye and a single vision contact lens in the fellow eye, if required. The progression of axial growth and refractive error will be measured and compared in each eye
  3. Subjects' aged between 8 and 15 with similar levels of hyperopia in each eye will be fitted with centre-near multifocal design contact lenses in each eye. The progression of axial growth and refractive error will be measured and compared to subjects in the natural progression study

Condition or disease Intervention/treatment Phase
Hyperopia Amblyopia Anisohyperopia Device: Multifocal contact lenses Device: Single vision contact lenses Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Peripheral Defocus on Axial Growth and Modulation of Refractive Error in Hyperopes
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Natural progession
Following the natural progression of axial growth and refractive error.
Experimental: Anisohyperopes - intervention eye
The more hyperopic eye will be fitted with a centre-near multifocal contact lens
Device: Multifocal contact lenses
Experimental: Hyperopes
Both eyes will be fitted with centre-near multifocal contact lenses.
Device: Multifocal contact lenses
Experimental: Anisohyperopes - fellow eye
The less hyperopic eye will be fitted with a single vision contact lens if required.
Device: Single vision contact lenses



Primary Outcome Measures :
  1. Measurement in axial length change in mm [ Time Frame: Three years ]
    Axial length measured at baseline. Intervention introduced six months after baseline measures for a period of two years. Final measures taken six months after removal of intervention. Total time frame of three years.


Secondary Outcome Measures :
  1. Measurement of refractive change in dioptres [ Time Frame: Three years ]
    Refraction measured at baseline. Intervention introduced six months after baseline measures for a period of two years. Final measures taken six months after removal of intervention. Total time frame of three years.



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Ages Eligible for Study:   5 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 5 and 19 years at the initial examination for the natural progression arm
  • Aged between 8 and 15 years at the initial examination for the intervention arms
  • Parents must have read, understood and signed informed consent form
  • Participants must have read, understood and signed assent form
  • Participants in the intervention groups agree to wear the prescribed contact lenses for a minimum of 10 hours per day, at least 6 days per week for the 2-year duration of the intervention period
  • Be in good general health with no contraindications to contact lens wear
  • Maximum manifest spherical refractive error of +6.00D
  • Maximum manifest cylindrical refractive error of -1.00D
  • Minimum anisometropia of 1.25D in the anisohyperopic group (mean spherical error)
  • Maximum anisometropia of 1.00D in the non-anisohyperopic group (mean spherical error)
  • Minimum mean spherical refractive error of +2.00D in the more hyperopic eye
  • Be competent at handling contact lenses and understand the instructions given to ensure safe wear.

Exclusion Criteria• Previous contact lens wear

  • Participating within another clinical study (even if it is only an observational study?)
  • Regular use of medication to treat ocular conditions
  • Current use of systemic medication that may impact upon successful contact lens wear or affect focusing ability
  • Known ocular or systemic disease
  • Findings identified during contact lens assessment that would preclude contact lens wear.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686879


Contacts
Contact: Ian G Beasley, DOptom +44 (0) 7798633536 beasleyi@aston.ac.uk
Contact: Nicola Logan, PhD +44 (0) 121 204 4128 n.s.logan@aston.ac.uk

Locations
United Kingdom
Eyesite Eyecare Centres Recruiting
Coventry, Walsgrave, United Kingdom, CV2 4BA
Contact: Ian Beasley, DOptom    07798633536    beasleyi@aston.ac.uk   
Contact: Nicola Logan, PhD    01212044128    n.s.logan@aston.ac.uk   
Principal Investigator: Ian Beasley, DOptom         
Aston University Recruiting
Birmingham, West Midlands, United Kingdom, B4 7ET
Contact: Ian G Beasley, DOptom    +44 (0) 7798633536    beasleyi@aston.ac.uk   
Contact: Nicola Logan, PhD    +44 (0) 121 204 4128    n.s.logan@aston.ac.uk   
Principal Investigator: Ian G Beasley, DOptom         
Sub-Investigator: Nicola Logan, PhD         
Sub-Investigator: Leon Davies, PhD         
Sub-Investigator: Fiona Cruickshank, BSc         
Sub-Investigator: Susie Jones, BSc         
Sponsors and Collaborators
Aston University
College of Optometrists

Responsible Party: Aston University
ClinicalTrials.gov Identifier: NCT02686879     History of Changes
Other Study ID Numbers: 150-2015-IB
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aston University:
hyperopes
axial length
peripheral defocus

Additional relevant MeSH terms:
Amblyopia
Hyperopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Refractive Errors