A Unified Index to Predict the Success Probability of Myopia Control

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05773118
Study type	Interventional
Source	Nova Southeastern University
Contact
Status	Withdrawn
Phase	N/A
Start date	January 2025
Completion date	January 2030

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05919654` - Clinical Evaluation of MyoCare in Europe (CEME)	N/A
Recruiting	`NCT03402100` - Eye Drops Study for Myopia Control in Schoolchildren	N/A
Recruiting	`NCT03865160` - Low-dose Atropine for Myopia Control in Children	Phase 2/Phase 3
Recruiting	`NCT06088225` - Myopia Preventing With Distance-image Screen	N/A
Not yet recruiting	`NCT06085430` - Kubota Glass Parameter Refinement Study	N/A
Not yet recruiting	`NCT06405711` - To Evaluate the Efficacy and Safety of an Defocus Lens in Slowing the Progression of Myopia	N/A
Recruiting	`NCT05881655` - Slow Myopia Progression With Different Irradiance Light	N/A
Recruiting	`NCT05761379` - Clinical Study of Light Therapy to Control Myopia Progression in Children	N/A
Not yet recruiting	`NCT05760911` - Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches	N/A
Recruiting	`NCT04722874` - Repeated Low-Level Red-Light Therapy and Orthokeratology in Fast-progressing Myopia Control	N/A
Not yet recruiting	`NCT06221592` - Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses	N/A
Completed	`NCT04806698` - Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia	N/A
Completed	`NCT04806763` - Myopia Control With Orthokeratology Contact Lenses in Spain	N/A
Completed	`NCT04806711` - Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children	N/A
Recruiting	`NCT05894382` - Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control	N/A
Completed	`NCT05683535` - Adverse Events Related to Low Dose Atropine
Completed	`NCT05300321` - DIMS-myopia Progression ADN Axial Length Growth	N/A
Withdrawn	`NCT03519490` - Can Distance Center and Near Center Multifocal Contact Lenses Control Myopia Progression in Children?	N/A
Completed	`NCT05372991` - Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop	Phase 1/Phase 2
Active, not recruiting	`NCT05373693` - Myopia-control Efficacy by Peripheral Defocus Lens (PDL)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.