Trial of an experimental soft contact lens designed to inhibit the progression of axial myopia in children.

Trial of an experimental frequent-replacement soft contact lens designed to correct vision and simultaneously produce myopic retinal defocus during distance and near vision in order to inhibit axial elongation of the eye and myopia progression in children.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000633684

Acronym

DIMENZ

Enrollment

Registered

2005-10-13

Start date

2005-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

A frequent replacement soft contact lens that both corrects vision and simultaneously produces myopic retinal defocus will be worn monocularly for 10 months by children with progressing myopia. The fellow eye will be corrected with a standard single vision frequent replacement soft contact lens. At cross-over (after 10 months) the identity of the eyes wearing the experimental and the single vision lenses will be reversed and the lenses will be worn for a further 10 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

11 Years to 14 Years

Healthy volunteers

Inclusion criteria

Progressing myopia, spherical equivalent refraction of -1.50 to -4.00, visual acuity of 6/6 or better, ability to independently handle contact lenses, prepared to wear contact lenses full-time for the duration of the study.

Exclusion criteria

Astigmatism > 0.75D, anisometropia > 1.00D, abnormal binocular vision, ocular pathology, systemic disease with ocular complications, active anterior surface disease that would preclude contact lens wear, inadequate fit of soft contact lenses.

Outcome results