Trial Outcomes & Findings for Accommodative Behaviors in Multifocal Contact Lenses (NCT NCT06064617)

Last Updated: 2026-01-08

Results Overview

Accommodative function will be compared using the Grand Seiko Autorefractor between the center distance and center near group. The instrument will record the patient's refractive error at near (40 cm), which is commonly used for near assessment in clinic. Patients place their head on a chin rest and look at targets at different distances. The examiner then pushes a button and the refractive error (in Diopters) is recorded from the instrument and placed in an excel file to be analyzed.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Up to two hours (1 hour in each lens)

Results posted on

2026-01-08

Participant Flow

Potential participants will be recruited in the following manners: * Word of mouth by the investigators among employees and visitors to the College of Optometry * Flyers * Email announcements distributed to the faculty, staff, and students at OSU * Electronic advertisement in the OSU Healthbeat * Phone calls to potentially eligible participants who are identified from a review of clinical records at the College of Optometry to identify those who wear soft contact lenses.

All participants had a baseline examination where baseline clinical measures were taken. At the follow up appointment, they would wear center-distance and center-near lenses in which measurements from the baseline exam were repeated. The order of the wear lenses (center-distance and center-near) were randomized between subjects.

Participant milestones

Participant milestones
Measure	Center Distance, Then Center Near Participants had clinical measurements taken with Center Distance lenses, then Center Near Lenses	Center Near, Then Center Distance Participants had clinical measurements taken with Center Distance lenses, then Center Near Lenses all within a visit that was 2 hours or less.
First Intervention (1 hour) STARTED	11	9
First Intervention (1 hour) COMPLETED	11	9
First Intervention (1 hour) NOT COMPLETED	0	0
Second Intervention (1 hour) STARTED	11	9
Second Intervention (1 hour) COMPLETED	11	9
Second Intervention (1 hour) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accommodative Behaviors in Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Center Distance, Then Center Near n=11 Participants Participants had clinical measurements taken with Center Distance lenses, then Center Near Lenses	Center Near, Then Center Distance n=9 Participants Participants had clinical measurements taken with Center-Near lenses, Then Center Distance lenses	Total n=20 Participants Total of all reporting groups
Age, Continuous	24.1 years STANDARD_DEVIATION 1.4 • n=18 Participants	23.2 years STANDARD_DEVIATION 0.4 • n=17 Participants	23.7 years STANDARD_DEVIATION 1.2 • n=35 Participants
Sex: Female, Male Female	8 Participants n=18 Participants	5 Participants n=17 Participants	13 Participants n=35 Participants
Sex: Female, Male Male	3 Participants n=18 Participants	4 Participants n=17 Participants	7 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=18 Participants	9 Participants n=17 Participants	20 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	2 Participants n=18 Participants	0 Participants n=17 Participants	2 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	2 Participants n=18 Participants	0 Participants n=17 Participants	2 Participants n=35 Participants
Race (NIH/OMB) White	7 Participants n=18 Participants	9 Participants n=17 Participants	16 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants

PRIMARY outcome

Timeframe: Up to two hours (1 hour in each lens)

Population: Every participant wore the center distance and center near lenses, we are comparing the clinical measures in all participants wearing the distance lenses to the clinical measures in all participants wearing the center near lenses.

Outcome measures

Outcome measures
Measure	Center Distatnce n=20 Participants Participants had clinical measurements taken with Center Distance lenses	Center Near n=20 Participants Participants had clinical measurements taken with Center-Near lenses
Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)	1.20 Diopters Standard Deviation 0.17	1.03 Diopters Standard Deviation 0.12

SECONDARY outcome

Timeframe: Up to two hours

Accommodation was assessed by monocular estimation method which is done with a clinical retinoscope, in which the examiner looks at the light reflex of the retina and the patient reads small print at 40 centimeters and the examiner uses lenses to neutralize the reflex

Outcome measures

Outcome measures
Measure	Center Distatnce n=20 Participants Participants had clinical measurements taken with Center Distance lenses	Center Near n=20 Participants Participants had clinical measurements taken with Center-Near lenses
Accommodation (in Diopters) Measured by Monocular Estimation Method (MEM)	0.59 Diopters Standard Error 0.08	0.18 Diopters Standard Error 0.08

SECONDARY outcome

Timeframe: Up to 2 hours

Accommodation measured with a monocular push-up was measured by the examiner bringing a small target close to the eye and the patient reports when the target gets blurry. These eye focusing tests and outcomes will be compared in the lens types.

Outcome measures

Outcome measures
Measure	Center Distatnce n=20 Participants Participants had clinical measurements taken with Center Distance lenses	Center Near n=20 Participants Participants had clinical measurements taken with Center-Near lenses
Accommodation (in Diopters) Measured by Monocular Push-Up	12.26 Diopters Standard Deviation 0.45	10.95 Diopters Standard Deviation 0.45

SECONDARY outcome

Timeframe: Up to 2 hours

Accommodation was assessed by accommodative facility which uses lenses to determine how many times a patient can clear a target in one minute by having the patient look at print 40 centimeters away and the examiner places a plus lens in front of the eye and the patient reports when the text is clear and the examiner flips the lens to a minus lens and the patient reports when the text is clear and this is done for one minute and cycles per minute are recorded

Outcome measures

Outcome measures
Measure	Center Distatnce n=20 Participants Participants had clinical measurements taken with Center Distance lenses	Center Near n=20 Participants Participants had clinical measurements taken with Center-Near lenses
Accommodation (in Cycles Per Minute) Measured by Accommodative Facility	14.05 Cycles per Minute Standard Deviation 0.78	12.15 Cycles per Minute Standard Deviation 0.78

SECONDARY outcome

Timeframe: Up to 2 Hours

Vergence measures will be completed by Modified Thorington will be assessed at distance (20 feet) which is a card with a light in the center. The patient holds up a red lens over their eye and they report where they see the line crossing the cards. This is recorded in prism diopters. This is tested with all lens types.

Outcome measures

Outcome measures
Measure	Center Distatnce n=20 Participants Participants had clinical measurements taken with Center Distance lenses	Center Near n=20 Participants Participants had clinical measurements taken with Center-Near lenses
Phoria (in Prism Diopters) Measured by Modified Thorington at Distance	0.53 Prism Diopters Standard Deviation 0.25	0.23 Prism Diopters Standard Deviation 0.25

SECONDARY outcome

Timeframe: Up to 2 hours

Vergence measures was completed with Modified Thorington will be assessed at near (40 centimeters), which is a card with a light in the center. The patient holds up a red lens over their eye and they report where they see the line crossing the cards. This is recorded in prism diopters. This is tested with all lens types.

Outcome measures

Outcome measures
Measure	Center Distatnce n=20 Participants Participants had clinical measurements taken with Center Distance lenses	Center Near n=20 Participants Participants had clinical measurements taken with Center-Near lenses
Phoria (in Prism Diopters) Measured by Modified Thorington at Near	-1.25 Prism Diopters Standard Deviation 0.88	0.05 Prism Diopters Standard Deviation 0.88

Adverse Events

Center Distance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Center Near

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

Ann Morrison

The Ohio State University

Phone: 614-247-0010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place