Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

• Sponsor: Essilor International (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00787579
• Collaborator: Queensland University of Technology (Other)
• Enrollment: 135
• Location: 1
• Arms: 3

Study Details

Study Description

Brief Summary

1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.

2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.

3. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Bifocal spectacles; Device: Prismatic bifocal spectacles	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bifocal spectacles	Device: Bifocal spectacles; +1.50D bifocal spectacles
Active Comparator: Prismatic bifocals	Device: Prismatic bifocal spectacles; +1.50D bifocal spectacles combined with 3Δ base-in prisms
No Intervention: Single vision spectacles

Outcome Measures

Primary Outcome Measures

1. Myopia progression, measured by cycloplegic autorefraction [Every 6 months]

Secondary Outcome Measures

1. Axial length, measured by A-scan ultrasonography [Every 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age: 8 to 13 years

• Myopia: -1.00 to -5.00 D

• Myopia progression: at least 0.50 D/yr

• Astigmatism and anisometropia: not more than 1.50 D

• Distance monocular visual acuity: 6/6 or better

• Near monocular visual acuity: 0.4 M or better

• Stereoacuity: not more than 40 sec of arc at 40 cm

Exclusion Criteria:

• Strabismus

• Ocular diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Desmond Cheng & Associates	Mississauga	Ontario	Canada	L5N 7G5

Sponsors and Collaborators

• Essilor International
• Queensland University of Technology

Investigators

• Principal Investigator: Desmond Cheng, OD, MSc, Queensland University of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00787579
• Other Study ID Numbers: Essilor
• First Posted: Nov 7, 2008
• Last Update Posted: Nov 7, 2008
• Last Verified: Nov 1, 2008

• Keywords provided by , ,: Myopia, bifocal, children
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Nov 7, 2008