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
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:
- 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
- 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
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- 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.
- 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.
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
|Contact: Ian G Beasley, DOptom||+44 (0) firstname.lastname@example.org|
|Contact: Nicola Logan, PhD||+44 (0) 121 204 email@example.com|
|Eyesite Eyecare Centres||Recruiting|
|Coventry, Walsgrave, United Kingdom, CV2 4BA|
|Contact: Ian Beasley, DOptom 07798633536 firstname.lastname@example.org|
|Contact: Nicola Logan, PhD 01212044128 email@example.com|
|Principal Investigator: Ian Beasley, DOptom|
|Birmingham, West Midlands, United Kingdom, B4 7ET|
|Contact: Ian G Beasley, DOptom +44 (0) 7798633536 firstname.lastname@example.org|
|Contact: Nicola Logan, PhD +44 (0) 121 204 4128 email@example.com|
|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|