MedTrace Logo

Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

NCT01515475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2019-07-16

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare visual acuity outcomes and development of strabismus after a 3-year follow-up period in children age 12 to \<72 months with moderate hyperopia (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only after confirmation of pre-specified deterioration criteria.

Conditions

  • Hyperopia

Interventions

PROCEDURE

Glasses

Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction.

Sponsors & Collaborators

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Marjean Kulp, OD, MS · Jaeb Center for Health Research

  • David Petersen, MD · Jaeb Center for Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-23
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT01515475 on ClinicalTrials.gov