A Unified Index to Predict the Success Probability of Myopia Control

September 8, 2023 updated by: Nova Southeastern University
Orthokeratology lenses (OK-lens) and multifocal contact lenses (MFCL) are optical devices designed to slow down the progression of myopia. Both treatments a long-term commitment from doctors and patients. This study aims to develop a unified index to predict the success probability of myopia control at the early stage of treatment.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

An Orthokeratology lens (OK-lens) is a rigid contact lens with a reverse geometry on its back surface. Overnight OK-lens wearing flattens the central cornea (creating minus power) and steepens the mid-peripheral cornea (creating plus power). During the day, this inverted pattern of peripheral corneal refraction induces relative peripheral myopic defocus on the retina to slow down the axial growth. The central portion of an MFCL is designed with minus powers to correct for distance vision, and plus power is directly added to the peripheral part of the lens. Daytime MFCL wear imposes peripheral retinal myopic defocus when the lenses are worn. An MFCL can also reduce axial growth by 52% compared to a single vision spectacle or contact lens.

Myopia control with OK-lens or MFCL requires a long-term commitment from doctors and patients to see the effect become apparent. It is paramount to estimate the probability that a patient would achieve effective control in myopic progression ideally before treatment begins or early during the course of treatment. To this end, efforts have been made to investigate the correlations between axial growth and possible contributing factors. Early research works have covered a variety of parameters at the baseline, including age, spherical equivalent (SE), corneal eccentricity, and corneal thickness. These measurements are nonspecific, indirect, and based on the assumption that their relationships to axial growth are linear, which often leads to contradictory findings and results that are hard to interpret by physicians. Therefore, in this study, we proposed a new index that takes pupil size into consideration by determining the summed relative myopic defocus dosage within the pupillary area (PMDD) to predict myopia control's success rate. This index will be determined for each eye, will be quantified one month after the lens dispensing, and will be used as the predictive variable.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

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

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

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Older than 7 years of age or younger than 12 years of age,
  • Spherical equivalent (SE) greater -1.00 D and less than-5.00 D,
  • Corneal astigmatism ≤ 1.50 D,
  • best-corrected visual acuity better than 20/25,
  • No binocular vision dysfunction,
  • No obvious angle kappa,
  • No history of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days,
  • No contact lens contraindications,
  • No related ocular or systemic disease.

Exclusion Criteria:

  • Younger than 7 years of age or older than 12 years of age,
  • Spherical equivalent (SE) less than -1.00 D or greater than-5.00 D,
  • Corneal astigmatism > 1.50 D,
  • Best-corrected visual acuity less than 20/25,
  • Binocular vision dysfunction,
  • Obvious angle kappa,
  • History of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days,
  • Contact lens contraindications,
  • Related ocular or systemic disease.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: orthokeratology lens
The subjects will wear an orthokeratology lens with 3-zone reverse geometry design. The subjects are instructed to wear the lenses for at least eight hours every night and are removed during daytime hours.
Device: orthokeratology lens
Subjects will wear orthokeratology lens at night. Axial length elongation over a period of 12-month will be recorded.
Experimental: multifocal soft contact lens
The subjects will wear a multifocal soft contact lens during daytime hours and remove the lens at night
Device: multifocal soft contact lens
Subjects will wear multifocal soft contact lens during the day time. Axial length elongation over a period of 12-month will be recorded.
Active Comparator: single vision spectacle
The subjects will wear single vision spectacle lens as control.
Device: Single vision spectacles
Subjects will wear single vision spectacles during the day. Axial length elongation over a period of 12-month will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
axial length elongation
Time Frame: over 12 months
The changes in axial length at the end of 12-month treatment will be computed.
over 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pupillary myopia defocus dosage
Time Frame: over 12 months
The myopia defocus dosage accumulated within the pupillary area
over 12 months

Collaborators and Investigators

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

Sponsor

Nova Southeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-597

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

Yes

product manufactured in and exported from the U.S.

Yes

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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