Trial Outcomes & Findings for Enhancement of Emmetropization in Highly Hyperopic Infants (NCT NCT03669146)

Last Updated: 2024-07-09

Results Overview

The subject's central refractive error will be measured (in Diopters) with cycloplegic retinoscopy to determine if partial refractive correction and accommodative training can enhance emmetropization in highly hyperopic infants. Successful enhancement is defined as being an average of 1.75 Diopters less hyperopic than control subjects at 18 months.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

18 months

Results posted on

2024-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Hyperopic Subjects Receiving Glasses Randomized +5.00 to +7.00 diopter hyperopic subjects that will receive partial refractive correction and will be instructed to do accommodation exercises on a daily basis. Glasses: Partial refractive correction in a pair of glasses.	Hyperopic Subjects Uncorrected Randomized +5.00 to +7.00 diopter hyperopic subjects that will serve as the control to the experimental arm who will receive no correction but be observed for the duration of the study.	Highly Hyperopic Subjects Corrected If a subject is found to be greater than +7.00 diopters hyperopic during the screening phase of the study, they will receive glasses correction and be followed during the study period. Glasses: Partial refractive correction in a pair of glasses.
Overall Study STARTED	15	15	5
Overall Study COMPLETED	13	14	5
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancement of Emmetropization in Highly Hyperopic Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyperopic Subjects Receiving Glasses n=15 Participants Randomized +5.00 to +7.00 diopter hyperopic subjects that will receive partial refractive correction and will be instructed to do accommodation exercises on a daily basis. Glasses: Partial refractive correction in a pair of glasses.	Hyperopic Subjects Uncorrected n=15 Participants Randomized +5.00 to +7.00 diopter hyperopic subjects that will serve as the control to the experimental arm who will receive no correction but be observed for the duration of the study.	Highly Hyperopic Subjects Corrected n=5 Participants If a subject is found to be greater than +7.00 diopters hyperopic during the screening phase of the study, they will receive glasses correction and be followed during the study period. Glasses: Partial refractive correction in a pair of glasses.	Total n=35 Participants Total of all reporting groups
Age, Continuous	81.9 Days STANDARD_DEVIATION 10.2 • n=39 Participants	79.0 Days STANDARD_DEVIATION 9.0 • n=41 Participants	78.6 Days STANDARD_DEVIATION 8.7 • n=35 Participants	80.2 Days STANDARD_DEVIATION 9.3 • n=31 Participants
Sex: Female, Male Female	9 Participants n=39 Participants	7 Participants n=41 Participants	4 Participants n=35 Participants	20 Participants n=31 Participants
Sex: Female, Male Male	6 Participants n=39 Participants	8 Participants n=41 Participants	1 Participants n=35 Participants	15 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=39 Participants	15 Participants n=41 Participants	5 Participants n=35 Participants	35 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants	1 Participants n=31 Participants
Race (NIH/OMB) White	14 Participants n=39 Participants	15 Participants n=41 Participants	4 Participants n=35 Participants	33 Participants n=31 Participants
Race (NIH/OMB) More than one race	1 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Region of Enrollment United States	15 participants n=39 Participants	15 participants n=41 Participants	5 participants n=35 Participants	35 participants n=31 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Subject numbers here do not match initial projected subject numbers due to participant drop outs (2 in hyperopic subjects receiving glasses; 1 in hyperopic subjects uncorrected)

Outcome measures

Outcome measures
Measure	Hyperopic Subjects Receiving Glasses n=13 Pairs of eyes Randomized +5.00 to +7.00 diopter hyperopic subjects that will receive partial refractive correction and will be instructed to do accommodation exercises on a daily basis. Glasses: Partial refractive correction in a pair of glasses.	Hyperopic Subjects Uncorrected n=14 Pairs of eyes Randomized +5.00 to +7.00 diopter hyperopic subjects that will serve as the control to the experimental arm who will receive no correction but be observed for the duration of the study.	Highly Hyperopic Subjects Corrected n=5 Pairs of eyes If a subject is found to be greater than +7.00 diopters hyperopic during the screening phase of the study, they will receive glasses correction and be followed during the study period. Glasses: Partial refractive correction in a pair of glasses.
Central Cycloplegic Refractive Error With Retinoscopy	1.6 Diopters Standard Deviation 0.6	1.2 Diopters Standard Deviation 0.7	2.8 Diopters Standard Deviation 1.2

SECONDARY outcome

Timeframe: 18 months

Population: Number analyzed is slightly less due to drop outs of participants (2 in treatment/hyperopic subjects with glasses; 1 observation/uncorrected no glasses)

The subject's central and peripheral refractive error will be measured (in Diopters) with the SureSight autorefractor to determine if partial refractive correction and accommodative training can enhance emmetropization through modulation of ocular shape in highly hyperopic infants.

Outcome measures

Outcome measures
Measure	Hyperopic Subjects Receiving Glasses n=13 Pairs of eyes Randomized +5.00 to +7.00 diopter hyperopic subjects that will receive partial refractive correction and will be instructed to do accommodation exercises on a daily basis. Glasses: Partial refractive correction in a pair of glasses.	Hyperopic Subjects Uncorrected n=14 Pairs of eyes Randomized +5.00 to +7.00 diopter hyperopic subjects that will serve as the control to the experimental arm who will receive no correction but be observed for the duration of the study.	Highly Hyperopic Subjects Corrected n=5 Pairs of eyes If a subject is found to be greater than +7.00 diopters hyperopic during the screening phase of the study, they will receive glasses correction and be followed during the study period. Glasses: Partial refractive correction in a pair of glasses.
Peripheral Cycloplegic Refractive Error With SureSight Autorefractor Central Spherical Equivalent Refractive Error	2.15 Diopters Standard Deviation 0.61	1.99 Diopters Standard Deviation 1.18	4.11 Diopters Standard Deviation 1.11
Peripheral Cycloplegic Refractive Error With SureSight Autorefractor Relative Nasal Spherical Equivalent Refractive Error	-0.28 Diopters Standard Deviation 0.89	-0.19 Diopters Standard Deviation 0.6	-0.52 Diopters Standard Deviation 0.25
Peripheral Cycloplegic Refractive Error With SureSight Autorefractor Relative Temporal Spherical Equivalent Refractive Error	-1.25 Diopters Standard Deviation 1.17	-0.81 Diopters Standard Deviation 0.77	-2.21 Diopters Standard Deviation 0.61

SECONDARY outcome

Timeframe: 18 months

Population: Final number analyzed slightly less due to participant drop out (2 in treatment/hyperopic subjects receiving glasses and 1 observation/hyperopic subjects uncorrected)

The subject's accommodative ability will be measured objectively with a PowerRefractor autorefractor to determine determine if partial refractive correction and accommodative training can enhance emmetropization through modulation of accommodation in highly hyperopic infants.

Outcome measures

Outcome measures
Measure	Hyperopic Subjects Receiving Glasses n=13 Pairs of eyes Randomized +5.00 to +7.00 diopter hyperopic subjects that will receive partial refractive correction and will be instructed to do accommodation exercises on a daily basis. Glasses: Partial refractive correction in a pair of glasses.	Hyperopic Subjects Uncorrected n=14 Pairs of eyes Randomized +5.00 to +7.00 diopter hyperopic subjects that will serve as the control to the experimental arm who will receive no correction but be observed for the duration of the study.	Highly Hyperopic Subjects Corrected n=5 Pairs of eyes If a subject is found to be greater than +7.00 diopters hyperopic during the screening phase of the study, they will receive glasses correction and be followed during the study period. Glasses: Partial refractive correction in a pair of glasses.
Accommodative Response With PowerRefractor	2.21 Diopters Standard Deviation 0.00	2.09 Diopters Standard Deviation 0.22	1.97 Diopters Standard Deviation 0.23

Adverse Events

Hyperopic Subjects Receiving Glasses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hyperopic Subjects Uncorrected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Highly Hyperopic Subjects Corrected

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 College of Optometry

Phone: 614-570-3416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place