Eye Length Signal With Myopia Control

NCT04813640 | Unknown

• 1 other identifier: VCRTC2020-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Myopia, considered as a global epidemic, is rapidly rising in prevalence especially in east Asian countries. Younger ages are associated with greater annual progression and thus early onset myopia is likely to result in higher levels of final net myopia.\[1\] Myopia, especially high myopia (more than -6.00D) is associated vision threatening complications such as cataract, glaucoma, choroidal thinning, vitreous liquefaction, myopic maculopathy, retinal detachment etc. Furthermore, myopia can affect the quality of life of an individual through restriction of employment in certain fields such as aviation. Myopia also imposes economic burden through the recurring cost of vision correction such as spectacles, contact lenses and specialist consultation fee. It is therefore important to develop novel optical and pharmaceutical strategies that can control or slow the progression of myopia.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Change in axial length

  Change in axial length measured using Lenstar

  one monthly interval for up to 6 months

Secondary Outcomes (1)

• Vision and Choroidal Physiology

  One monthly interval for up to 6 months

Study Arms (4)

Single Vision Spectacles

PLACEBO COMPARATOR

Commercially available conventional single vision spectacles

Device: Spectacles

Commercially available myopia control spectacles

ACTIVE COMPARATOR

Commercially available myopia control spectacles

Device: Spectacles

Novel Myopia control spectacles - Prototype I

EXPERIMENTAL

Experimental myopia control spectacles

Device: Spectacles

Novel Myopia control spectacles - Prototype II

EXPERIMENTAL

Experimental myopia control spectacles

Device: Spectacles

Interventions

Spectacles DEVICE

Novel spectacles for myopia control

Commercially available myopia control spectacles; Novel Myopia control spectacles - Prototype I; Novel Myopia control spectacles - Prototype II; Single Vision Spectacles

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• be aged between 7 to 14 completed years (7 and 14 years inclusive), irrespective of gender.
• have cycloplegic autorefraction spherical component -0.50 D to - 4.50D, cylinder no more than -1.50D
• be accompanied by parents/guardians who can read and comprehend Vietnamese and give informed consent as demonstrated by signing a record of informed consent.
• be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
• have ocular health findings considered to be "normal".
• be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
• be willing to wear the spectacles provided by the investigators for all waking hours;

You may not qualify if:

• A known allergy to, or a history of intolerance to tropicamide or topical anaesthetics;
• Strabismus and/or amblyopia;
• Had previous eye surgery (including strabismus surgery);
• Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes;
• Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids;
• Worn bifocals or progressive addition spectacles;
• Worn orthokeratology or bifocal contact lenses;
• Current orthoptic treatment or vision training;
• Any anatomical, skin or other condition that would impact on the wearing of spectacles;
• Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
• Concurrently enrolled in another clinical trial.

Sponsors & Collaborators

• Brien Holden Vision Institute: lead

Study Sites (1)

Hai Yen Eye Care Center

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Minh Huy Tran, M.D., Msc.

  Hai Yen Eye Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minh Huy Tran, M.D., Msc.

CONTACT

(+84) 907 110 892; huy.tran@haiyeneyecare.com

Padmaja Sankaridurg, BOpt, PhD

CONTACT

612 93857485; p.sankaridurg@bhvi.org

Study Design

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

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: March 24, 2021
• Study Start: February 5, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)