Trial Outcomes & Findings for Ocular Adaptation and Visual Performance for Accommodative Contact Lens (NCT NCT02923232)
NCT ID: NCT02923232
Last Updated: 2023-05-03
Results Overview
Participants will wear the test lens and look at different downsize angles. The refractive power of the lens/eye combination will be measured with an open-field auto refractor.
TERMINATED
NA
52 participants
30 mins of wearing; non-dispensing.
2023-05-03
Participant Flow
This study involved few participants recruited from Pacific University and designated clinics. It went through 3 iterations in lens design changes and less than 10 subjects in each iteration.
Subjects were recruited in 3 separate iterations. They were not assigned to different groups, and were tested with the same test lens with minor modification. This is considered a phase 1 study.
Participant milestones
| Measure |
Accommodative Contact Lens
This was a study involving only the test contact lens. There is no control condition.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Baseline characteristics by cohort
| Measure |
Accommodative Contact Lens
n=52 eyes
The accommodative contact lens is composed of traditional hydrogel lens material but has an internal cavity to allow lens deformation that increases its refractive power at an downward angle.
Accommodative contact lens: Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.
|
|---|---|
|
Age, Customized
Age at the entrance date
|
52.6 year
STANDARD_DEVIATION 14.2 • n=52 Participants
|
|
Sex: Female, Male
Female
|
32 eyes
n=52 eyes
|
|
Sex: Female, Male
Male
|
20 eyes
n=52 eyes
|
|
Monocular visual acuity
|
.4 logMAR
STANDARD_DEVIATION .23 • n=52 eyes
|
PRIMARY outcome
Timeframe: 30 mins of wearing; non-dispensing.Population: Presbyopes who require distance optical correction
Participants will wear the test lens and look at different downsize angles. The refractive power of the lens/eye combination will be measured with an open-field auto refractor.
Outcome measures
| Measure |
Accommodative Contact Lens
n=52 eyes
This was a study involving only the test contact lens. There is no control condition.
|
|---|---|
|
Monocular Refractive Power
|
-1.5 Diopter
Standard Deviation 2.42
|
PRIMARY outcome
Timeframe: 30 mins of wearing; non-dispensing.Population: Presbyopes who require distance optical correction
The resultant visual acuity at near at this down-gaze angle will be measured. This is achieved by having the subjects holding a new acuity chart at 40 cm distance, their heads upright and perpendicular to the ground, and their gazes rotated downward 20 degrees where the chart was located. The subjects then read out the optotypes (letters) on the chart to a size they cannot no only identify the letters. The lines of letters with which all letters can be identified is recorded as the corresponding level of acuity.
Outcome measures
| Measure |
Accommodative Contact Lens
n=52 Participants
This was a study involving only the test contact lens. There is no control condition.
|
|---|---|
|
Visual Acuity at 20 Degree Downsize Angles
|
0.24 logMAR
Standard Deviation 0.22
|
Adverse Events
Accommodative Contact Lens
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60