Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study

July 18, 2022 updated by: Pauline Cho, The Hong Kong Polytechnic University
This project aims to study the effects of treatment characteristics on myopia control in orthokeratology by investigating the effects of modified treatment zone by reducing the lens back optic zone diameter on the effect of myopia control. The project will be a two-year randomized, double-masked (examiner - mask axial length only) study conducted at The Hong Kong Polytechnic University recruiting sixty Chinese subjects aged between 6-11. Subjects will be randomly assigned to two ortho-k groups. The Control group will wear KATT BeFree lens with a BOZD of 6mm while the Test group will wear KATT MC lens with a modified BOZD of 5mm.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Orthokeratology (Ortho-k) treatment reduces the degree of myopia of the eye by flattening the central cornea. This central flattened zone is referred to as the treatment zone (TZ). Munnerlyn's formula describes the negative correlation between refractive correction and treatment zone size given a maximum ablation depth limited by the patient's corneal thickness in refractive surgery. This implies smaller TZ for higher myopic reduction and, indeed, a study found marginally smaller TZ of 0.3mm in higher myopic group. In ortho-k, it has been speculated that TZ may be associated with the effect of the treatment. The TZ is defined as the central flattened area enclosed by points with zero power/curvature changes comparing to pre-treatment condition on various topography maps.

Previous studies determine the TZ characteristics based on different types of topographical subtractive maps including tangential, axial and refractive maps. A study compared TZ parameters derived from the three different maps. The study defined the TZ as the area enclosed by zero power change in different subtractive maps; 12 such points equally spaced 30 degree apart to construct a best-fit ellipse. Geometrical center of this ellipse was used to determine the TZ decentration and TZ diameter along vertical and horizontal axes. The study found significantly less TZ decentration and diameter in tangential map comparing to axial and refractive maps and no significant difference between the latter two. Based on these findings, the investigators suggested that either refractive or axial map would be of high validity and accuracy in determining TZ characteristics.

The current study would investigate the effect of TZ on myopic control in ortho-k. TZ, defined as the area enclosed by zero power change in subjective maps will be employed. The tangential and refractive subtractive maps will be used to determine the TZ. Characteristics of the TZ, including diameter, slope, depth, volume, would be analyzed based on topographical subtractive maps and the effect of each of these characteristics on myopia control will be evaluated. The role of pupil size during normal viewing condition (distance and near) will also be investigated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • School of Optometry, The Hong Kong Polytechnic University
      • Kowloon, Hong Kong
        • School of Optometry

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Modified ortho-k lenses
Participants wearing ortho-k lens with a modified BOZD of 5mm
Device: Modified ortho-k lenses
KETT MC lens
Active Comparator: Ortho-k lenses
Participants wearing ortho-k lens with a standardized BOZD of 6mm
Device: Ortho-k lenses
KATT BeFree lens

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in axial length before and after two years of lens wear
Time Frame: 2 years
To determine the change in axial length measured at baseline and two years after lens wear using IOLMaster
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment zone characteristics
Time Frame: 2 years
Corneal topography will be determined by Medmont topographer and the treatment zone characteristics will be determined from the subtractive maps
2 years
Pupil sizes
Time Frame: 2 years
Photopic and mesotopic pupil sizes
2 years
Choroidal thickness
Time Frame: 2 years
Choroidal thickness measurement will be determined by both LenStar and posterior OCT
2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20170118004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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