Clinical Trials Logo
  1. Home
  2. Amblyopia
  3. NCT00038753
  4. Details
NCT00038753 Clinical Trial

Vision In Preschoolers Study (VIP Study)

Amblyopia Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00038753
Other study ID # NEI-85
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received June 4, 2002
Last updated October 15, 2009

Study information
Verified date October 2009
Source National Eye Institute (NEI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

To identify vision-screening tests that can accurately predict those three- and four-year old preschoolers who would benefit from a comprehensive vision examination because of signs of amblyopia, strabismus, and/or significant refractive error.

Description:

The Vision In Preschoolers (VIP) Study is a multi-center, multidisciplinary, prospective clinical study to evaluate screening tests for identifying preschool children in need of comprehensive eye examinations. The primary goal of the VIP Study is to identify an effective and efficient battery of screening tests that has high sensitivity and specificity in identifying preschoolers in need of further evaluation for amblyopia, strabismus and/or significant refractive error.

The VIP Study is designed in three-phases.

Phase I activities will establish which screening tests perform well when administered by licensed eye care professionals (pediatric optometrists and pediatric ophthalmologists) in a population of 1000 Head Start preschoolers at high risk for the targeted vision disorders.

Phase II activities will provide evaluation of the tests' performance when administered by pediatric nurses and lay people on a high risk population of 1000 Head Start preschoolers. Each child will be tested twice with each screening test - once by a pediatric nurse and once by a lay screener. Tests selected for Phase II will be determined by the outcome of Phase I.

Phase III activities will evaluate the performance of the tests in identifying individuals with specific vision disorders in a general population of (6400) Head Start preschoolers. The category of screening personnel and the specific screening tests used in Phase III will be determined by the outcome of Phases I and II.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 36 Months to 59 Months
Eligibility Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Vision Screening

Locations
Country Name City State
United States University of California, Berkeley School of Optometry Berkeley California
United States New England College of Optometry Boston Massachusetts
United States The Ohio State University College of Optometry Columbus Ohio
United States Pennsylvania College of Optometry Philadelphia Pennsylvania
United States Oklahoma Northeastern State University College of Optometry Tahlequah Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Recruiting NCT04238065 - A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia N/A
Completed NCT04432181 - Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Terminated NCT02767856 - Regimens of Intermittent Occlusion Therapy for Amblyopia in Children N/A
Completed NCT02458846 - Efficacy of Visual Screening in Ontario N/A
Completed NCT01190813 - Levodopa for the Treatment of Residual Amblyopia Phase 3
Completed NCT01109459 - Multimodal Physician Intervention to Detect Amblyopia N/A
Completed NCT04313257 - Monocular Action Video Game Treatment of Amblyopia N/A
Completed NCT04315649 - Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops N/A
Completed NCT05223153 - OCT-A and Amblyopia
Recruiting NCT05522972 - Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games N/A
Completed NCT01430247 - Vision Screening for the Detection of Amblyopia N/A
Completed NCT02200211 - Study of Binocular Computer Activities for Treatment of Amblyopia N/A
Recruiting NCT06429280 - Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Withdrawn NCT04959422 - Assuring Ophthalmologic Follow up N/A
Active, not recruiting NCT05612568 - 5 Years of Eye Screening for ARF in Children Aged <3 Years in Flanders
Recruiting NCT03655912 - Binocular Visual Therapy and Video Games for Amblyopia Treatment. N/A
Recruiting NCT06150391 - Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program N/A
Completed NCT03754153 - Binocularly Balanced Viewing Study N/A
Withdrawn NCT02594358 - Caffeine in Amblyopia Study Phase 1/Phase 2
Terminated NCT02246556 - Dichoptic Virtual Reality Therapy for Amblyopia in Adults Phase 1