A single-centre, prospective, randomized, single-masked, controlled clinical trial to evaluate the DIMSHYP spectacle lenses visual performance and reduction of hyperopia in children - NI

Dr. Agarwal’s Eye Hospital Limited0 sites0 target enrollmentTBD

Overview

Phase: 未知
Intervention: Not specified
Conditions: Health Condition 1: H533- Other and unspecified disorders ofbinocular vision
Sponsor: Dr. Agarwal’s Eye Hospital Limited
Status: Not yet recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

Dr. Agarwal’s Eye Hospital Limited

•1\.Subjects’ age at time of parent (or guardian) consent and subject assent: 6 \-9 years old.
•2\.Subjects with cycloplegic autorefraction SER between \+2\.00 D and \+6\.50 D.
•3\.Subjects with cycloplegic autorefraction astigmatism of 1\.50 D or less.
•4\.Subjects with cycloplegic autorefraction anisometropia of 1\.50 D or less.
•5\.Subjects with monocular best\-corrected distance visual acuity (BCDVA) under cycloplegic equal to or better than logMAR 0\.08 (better than 20/25\).
•6\.Subjects in which baseline 3D macula optical coherence tomography (OCT) volume scan can clearly measure sub\-foveal choroidal thickness.
•7\.Subjects and parents (or LAR) are able and willing to provide oral/verbal assent and consent, respectively.
•8\.Subjects and parents (or LAR) assure to attend required study visits and adhere to participant requirements.
•9\.The parent (or LAR) understands and accepts random allocation of grouping, and the subject and parent (or LAR) will not know the allocated group.
•10\.Subjects are willing to wear the study spectacle lens for a minimum of 12 hours per day for the duration of the study

•1\.Subjects with an allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops.
•2\.Subjects with any ocular and systemic abnormalities that might be expected to affect visual functions or refractive development.
•3\.Subjects with prior treatment of hyperopic control six months prior to the screening.
•4\.Subjects with clinically significant strabismus orbinocular vision abnormalities
•5\.Subjects with amblyopia or history of amblyopia.
•6\.Subjects with previous intraocular surgery.
•7\.Subjects with participation in a clinical trial within 30 days before the study entry into this study.
•8\.Subjects with presence of any emotional, physiologic or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment, based on the clinical judgment of the investigator.
•9\.Subjects with any medical treatment or medication which might influence the vision or interfere with study assessments.

Not specified