Trial Outcomes & Findings for Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes (NCT NCT05250206)

Results Overview

Axial length was measured with the IOL Master® optical biometer (Carl Zeiss Meditec, Jena, Germany) and axial length growth was calculated by subtracting the axial length measurement after one year of treatment and the axial length at the initial visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

5 minutes

Results posted on

2025-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Control Lens Standard spherocylindrical lenses.	Treatment Lens Lenses with a central zone that provides the patient's optimal prescription surrounded by a zone of positive defocus that increases progressively from the center to the periphery of the lens, in an asymmetrical manner between the different zones of the lens.
Overall Study STARTED	46	46
Overall Study COMPLETED	34	35
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=34 Participants The control group consisted of 34 children using standard spherocylindrical lenses.	Treatment Group n=35 Participants The treatment group included 35 children wearing a prototype lens with a central zone that provides the patient's optimal prescription surrounded by a zone of positive defocus that increases progressively from the center to the periphery of the lens, in an asymmetrical manner between the different zones of the lens.	Total n=69 Participants Total of all reporting groups
Age, Continuous	9.6 years STANDARD_DEVIATION 1.8 • n=5 Participants	10.4 years STANDARD_DEVIATION 1.8 • n=7 Participants	10.0 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	23 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Spanish children	34 participants n=5 Participants	35 participants n=7 Participants	69 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes

Axial length was measured with the IOL Master® optical biometer (Carl Zeiss Meditec, Jena, Germany) and axial length growth was calculated by subtracting the axial length measurement after one year of treatment and the axial length at the initial visit.

Outcome measures

Outcome measures
Measure	Myopia Control Lens n=34 Participants The control group consisted of 42 children using standard spherocylindrical lenses.	Treatment Group n=35 Participants The treatment group included 41 children wearing a prototype lens with a central zone that provides the patient's optimal prescription surrounded by a zone of positive defocus that increases progressively from the center to the periphery of the lens, in an asymmetrical manner between the different zones of the lens.
Axial Lenght Increase	0.27 mm Standard Deviation 0.23	0.37 mm Standard Deviation 0.24

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Indizen Optical Technologies (Madrid), Universidad Complutense de Madrid

Phone: +34 (91) 833 37 86

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place