Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes

Myopia Clinical Trial

Official title:

Evaluation of Ophthalmic Lenses for Myopia Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250206
• Other study ID #: IOT-MIO-2018-01
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: February 2022
• Source: Indizen Optical Technologies, S.L.U.
• Contact: Eva Chamorro, Phd
• Phone: +34 (91) 833 37 86
• Email: evachamorro[@]iot.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age: 5 to 12 years old

• Myopia (spherical equivalent with cycloplegic) = -0.50D

• Astigmatism < 1.50D

• Anisometropia < 1.50D

• Best-corrected visual acuity = 20/20

Exclusion Criteria:

• Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses.

• Participants with ocular pathology such as retinal detachment.

• Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface.

• Participants with systemic diseases that may affect vision.

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Myopia control lens
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Locations

Country	Name	City	State
Spain	Universidad Europea of Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Indizen Optical Technologies, S.L.U.	Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Hasebe S, Jun J, Varnas SR. Myopia control with positively aspherized progressive addition lenses: a 2-year, multicenter, randomized, controlled trial. Invest Ophthalmol Vis Sci. 2014 Sep 30;55(11):7177-88. doi: 10.1167/iovs.12-11462. — View Citation

Kanda H, Oshika T, Hiraoka T, Hasebe S, Ohno-Matsui K, Ishiko S, Hieda O, Torii H, Varnas SR, Fujikado T. Effect of spectacle lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese children: a 2-year multicenter randomized controlled trial. Jpn J Ophthalmol. 2018 Sep;62(5):537-543. doi: 10.1007/s10384-018-0616-3. Epub 2018 Aug 6. — View Citation

Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	Measure of axial length with a biometer	5 minutes
Primary	Refraction	Binocular refraction with autorefractometer under cyclopegia	5 minutes