NCT06726499

Brief Summary

Background/Objectives: To examine the trend of treatment zone (TZ) decentration over 12 months of Orthokeratology (OK) wear using two corneal refractive therapy (CRT) lens designs: standard (STD) and dual axis (DA). Methods: A prospective, randomized, longitudinal study was conducted at the Optometry Clinic of the Complutense University of Madrid. Subjects were fitted with STD or DA designs in one of the eyes, randomly. Refraction, uncorrected visual acuity (VA) and corneal topography were performed at baseline, 1-night, 1-week, 1-, 3-, 6- and 12-month of lens wear. Subjects requiring lens parameter adjustments or replacements after 3 months were excluded. Decentration was measured by subtracting pre-OK from post-OK tangential curvature maps at each visit, with decentration distance and corneal optical TZ measured using MATLAB. Correlations between decentration and visual acuity (VA) were also analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2018

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

6 days

First QC Date

December 5, 2024

Last Update Submit

December 9, 2024

Conditions

Myopia Progression

Keywords

myopia; orthok

Outcome Measures

Primary Outcomes (1)

  • contact lens centration

    1 year

Study Arms (2)

spherical design

EXPERIMENTAL
Device: Spherical CRT

Toric Design

EXPERIMENTAL
Device: Toric CRT

Interventions

Spherical CRTDEVICE

Contact lens for myopia progression

spherical design
Toric CRTDEVICE

Contact lens for myopia progression

Toric Design

Eligibility Criteria

AgeUp to 17 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age between 8 to 17 years old
  • Myopia up -6.00 D

You may not qualify if:

  • Ocular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Complutense of Madrid

Madrid, Madrid, 28032, Spain

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 10, 2024

Study Start

June 9, 2018

Primary Completion

June 15, 2018

Study Completion

June 12, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations

ES(1)