The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology

May 4, 2022 updated by: Tianjin Eye Hospital
Orthokeratology lens is an effective method for myopia control. This study analyzed the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens.

Study Overview

Status

Completed

Conditions

Detailed Description

Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.

Study Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • TianJin eye hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Myopia children with orthokeratology lens and complete follow-up.

Description

Inclusion Criteria:

  • age from 8 to 15years
  • spherical equivalent(SE) was range from -1.00D to -5.00D
  • conform to the standard of wearing orthokeratology lens

Exclusion Criteria:

  • ocular diseases and systemic diseases
  • stop wearing for ≥7 days for any reason during the follow-up period
  • keratoconjunctival complications, glare, diplopia, or any other symptoms during follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of axial length
Time Frame: The change of baseline、6 months and 12months
The axial length was measured by IOL-Master 500, its expressed in mm
The change of baseline、6 months and 12months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the decentration magnitudes of the treatment zone
Time Frame: up to 1 year
The value of decentration magnitudes was obtained and calculated from a corneal topography
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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