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Assess the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.

NCT06023108 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-09-13

No results posted yet for this study

Summary

Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping the corneal epithelium to change refractive power. Due to its contact with the ocular surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well as changes in tear film stability. This prospective study randomly divided 300 children and adolescents with myopia into OK group and spectacles group, with a follow-up of 12 months. At baseline, 1, 3, 6, and 12 months, non-invasive tear breakup time (NIBUT), ocular surface disease index (OSDI) and visual analogue score (VAS) score, tear meniscus height (TMH), conjunctival hyperemia (RS score) and meibomian gland (MG) scores, tear MMP-9 concentration, and point-of-care Lymphotoxin alpha (LTA) test.

Conditions

Interventions

DEVICE

Orthokeratology

OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.

DEVICE

Spectacles

Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.

Sponsors & Collaborators

  • He Eye Hospital

    lead OTHER

Principal Investigators

  • Emmanuel Eric E Pazo, PHD · He Eye Hospital, Shenyang, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-23
Primary Completion
2023-11-30
Completion
2024-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023108 on ClinicalTrials.gov