Effect of Peripheral Defocus on Axial Growth in Hyperopes

NCT02686879 | Completed

• 1 other identifier: 150-2015-IB
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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. 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. 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. 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

Conditions

Hyperopia; Amblyopia; Anisohyperopia

Keywords

hyperopes; axial length; peripheral defocus

Outcome Measures

Primary Outcomes (1)

• Measurement in axial length change in mm

  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.

  Three years

Secondary Outcomes (1)

• Measurement of refractive change in dioptres

  Three years

Study Arms (4)

Natural progession

NO INTERVENTION

Following the natural progression of axial growth and refractive error.

Anisohyperopes - intervention eye

EXPERIMENTAL

The more hyperopic eye will be fitted with a centre-near multifocal contact lens

Device: Multifocal contact lenses

Hyperopes

EXPERIMENTAL

Both eyes will be fitted with centre-near multifocal contact lenses.

Device: Multifocal contact lenses

Anisohyperopes - fellow eye

EXPERIMENTAL

The less hyperopic eye will be fitted with a single vision contact lens if required.

Device: Single vision contact lenses

Interventions

Multifocal contact lenses DEVICE

Anisohyperopes - intervention eye; Hyperopes

Single vision contact lenses DEVICE

Anisohyperopes - fellow eye

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aston University: lead
• College of Optometrists: collaborator

Study Sites (2)

Eyesite Eyecare Centres

Coventry, Walsgrave, CV2 4BA, United Kingdom

Location

Aston University

Birmingham, West Midlands, B4 7ET, United Kingdom

Location

Related Publications (1)

• Beasley IG, Davies LN, Logan NS. Effect of Peripheral Defocus on Axial Eye Growth and Modulation of Refractive Error in Hyperopes: Protocol for a Nonrandomized Clinical Trial. JMIR Res Protoc. 2018 Sep 5;7(9):e173. doi: 10.2196/resprot.9320.

  PMID: 30185407 DERIVED

MeSH Terms

Conditions

Hyperopia; Amblyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 22, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: February 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)