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

NCT02955927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2021-08-10

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

DRUG

0.01% atropine eye drops

DEVICE

ortho-k

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER
  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Pauline Pauline, PhD · The Hong Kong Polytechnic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2021-05-08
Completion
2021-05-08

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955927 on ClinicalTrials.gov