Combined Atropine With Orthokeratology in Childhood Myopia Control (AOK) -A Randomized Controlled Trial

• Status: Completed
• Trial end date: 2021-05-08
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to compare effects in retardation of myopia progression of combined ortho-k and 0.01% atropine therapy with those of ortho-k alone.Myopia control methods mainly focus on optical and pharmaceutical interventions . Currently, overnight-wear orthokeratology (ortho-k), is used extensively in Hong Kong with approximately 50% retardation effect. Pharmaceutical methods have focused on the use of atropine eye drops to slow myopic progression.The use of 1% atropine was limited by the manifestation of side effects and rebound effect.However, both side effect and rebound effect was minimal with 0.01% atropine.It was suggested that 0.01% was the optimum concentration for controlling myopia.The mechanisms of neither ortho-k nor atropine in myopia control are fully understood.It is believed that ortho-k and atropine act via different mechanisms.It is possible that by combining these two methods, additional retardation of myopia progression could be achieved.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Hong Kong Polytechnic University
• Collaborator: The University of Hong Kong
• Treatments: Atropine; Ophthalmic Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• Manifest myopia between 1.00-4.00D in both eyes at screening visit

• Manifest astigmatism ≤2.50D; with-the-rule astigmatism (axes 180 ± 30) ≤2.50D; astigmatism with other axes ≤0.50D in both eyes at screening visit

• <1.00D difference in manifest spherical equivalent (SE) between the two eyes at screening visit

• Baseline cycloplegic objective refraction between 1.00-4.00D in sphere; astigmatism ≤2.50D; <1.00D difference in manifest SE between the two eyes

• Best-corrected logMAR visual acuity 0.10 or better in both eyes

• Symmetrical corneal topography with corneal toricity <2.00D in either eye

• Normal ocular health other than myopia

• Agree to be randomized and to attend the scheduled visits and aftercare

Exclusion Criteria:

• Contraindications to atropine: known allergies or cardiovascular disease, epilepsy

• Contraindications to contact lens wear and ortho-k: corneal scar, history of ocular inflammation/infection, limbus-to-limbus corneal cylinder and dislocated corneal apex

• Strabismus or amblyopia

• History of myopia control treatment (e.g. soft contact lenses, progressive add spectacles, atropine eye drops)

• Rigid contact lens (including ortho-k) wear experience

• Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)

• Ocular conditions which might affect refractive error (for example, cataract, ptosis)

• Poor response to lens wear including poor lens handling, poor vision and/ocular response after lens modifications

• Poor compliance with schedule visits