Trial Outcomes & Findings for Extended Depth of Focus Contact Lenses for Presbyopia (NCT NCT05495971)

NCT ID: NCT05495971

Last Updated: 2024-12-16

Results Overview

High contrast/high illumination distant (6M) logMAR vision

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

4 hours

Results posted on

2024-12-16

Participant Flow

Participant milestones

Participant milestones
Measure
Presbyopia
Subject's baseline vision will be compared with vision wearing treatment product NaturalVue Multifocal: EDOF
Overall Study
STARTED
24
Overall Study
COMPLETED
24
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Presbyopia
n=24 Participants
Subject's baseline vision will be compared with vision wearing treatment product NaturalVue Multifocal: EDOF
Age, Categorical
<=18 years
0 Participants
n=24 Participants
Age, Categorical
Between 18 and 65 years
23 Participants
n=24 Participants
Age, Categorical
>=65 years
1 Participants
n=24 Participants
Age, Continuous
59.2 years
n=24 Participants
Sex: Female, Male
Female
19 Participants
n=24 Participants
Sex: Female, Male
Male
5 Participants
n=24 Participants
Region of Enrollment
United States
24 participants
n=24 Participants
Visual acuity
-0.07 logMAR
STANDARD_DEVIATION 0.07 • n=24 Participants

PRIMARY outcome

Timeframe: 4 hours

High contrast/high illumination distant (6M) logMAR vision

Outcome measures

Outcome measures
Measure
Presbyopia
n=24 Participants
Subject's baseline vision will be compared with vision wearing treatment product NaturalVue Multifocal: EDOF
LogMAR Visual Acuity
-0.07 logMAR
Standard Deviation 0.07

Adverse Events

Presbyopia

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

Dr. Douglas P. Benoit

Visioneering Technologies, Inc.

Phone: 6035459507

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place