NCT00249275

Brief Summary

The aim of this study was to compare the effectiveness of two interventions, namely providing free spectacles or only a prescription to students with insufficiently corrected or uncorrected significant refractive errors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
Last Updated

November 7, 2005

Status Verified

January 1, 2004

First QC Date

November 3, 2005

Last Update Submit

November 3, 2005

Conditions

Under- and Uncorrected Significant Refractive Errors

Keywords

significant refractive errorschildrenspectaclesAfrica

Outcome Measures

Primary Outcomes (1)

  • The proportion of students who had been given/prescribed spectacles who were wearing spectacles 3 and 6 months later

Interventions

spectaclesDEVICE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of un- or undercorrected significant refractive error
  • form 1 student in participating secondary schools

You may not qualify if:

  • presenting VA of 6/12 or better in both eyes and no hyperopia of +2D or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Secondary Schools

Dar es Salaam, Dar es Salaam Region, Tanzania

Location

MeSH Terms

Interventions

Eyeglasses

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Clare Gilbert, Reader

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

January 1, 2004

Study Completion

August 1, 2004

Last Updated

November 7, 2005

Record last verified: 2004-01

Locations

TA(1)