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Trial Outcomes & Findings for Hyperopia Correction Using the NTK Optimal Keratoplasty (Opti-K) System (NCT NCT01028937)

NCT ID: NCT01028937

Last Updated: 2019-05-09

Results Overview

The proportion of eyes (target: at least 85%) that achieve successful distance uncorrected visual acuity (D-UCVA) improvement defined as 2 lines (10 letters) or more improvement in D-UCVA following Tx will be reported

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

1 year post-treatment

Results posted on

2019-05-09

Participant Flow

Participant milestones

Participant milestones
Measure
Hyperopia
The NTK Optimal Keratoplasty System/Procedure is indicated for the temporary improvement of distance uncorrected visual acuity (in patient eyes that have manifest refraction, spherical equivalent equal to +1.0 to +2.5 Diopters, with less than or equal to 0.75 Diopters of refractive astigmatism (minus cylinder format) and with uncorrected distance visual acuity less than 20/40 but greater than or equal to 20/80. Patients must be at least 40 years of age with a documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.5 Diopters in MRSE. The magnitude of D-UCVA improvement by Opti-K treatment may diminish over time, caused by some regression of effect in addition to natural progressive loss of accommodation and, for most patients, progressive hyperopic shift with increasing age. Optimal Keratoplasty: Laser treatment in 16 spots at treatment energy densities up to 48 mJ per spot
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hyperopia Correction Using the NTK Optimal Keratoplasty (Opti-K) System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Hyperopia
n=6 Participants
Hyperopia treatment
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Age, Continuous
59.8 years
STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 year post-treatment

Population: Eyes

The proportion of eyes (target: at least 85%) that achieve successful distance uncorrected visual acuity (D-UCVA) improvement defined as 2 lines (10 letters) or more improvement in D-UCVA following Tx will be reported

Outcome measures

Outcome measures
Measure
Treatment Group
n=5 Eyes
Eyes that underwent Opti-K treatment
The Proportion of Eyes (Target: at Least 85%) That Achieve Successful Distance Uncorrected Visual Acuity (D-UCVA) Improvement Defined as 2 Lines (10 Letters) or More Improvement in D-UCVA Following Tx Will be Reported.
4 Eyes

SECONDARY outcome

Timeframe: 1 year post-treatment

Population: 1 year follow-up

The proportion of eyes that achieve distance uncorrected visual acuity (D-UCVA) of 20/40 or better following Tx and the proportion of eyes that achieve D-UCVA of 20/40 or better as a function of the pre-Tx D-UCVA will both be reported.

Outcome measures

Outcome measures
Measure
Treatment Group
n=5 Eyes
Eyes that underwent Opti-K treatment
The Proportion of Eyes That Achieve Distance Uncorrected Visual Acuity (D-UCVA) of 20/40 or Better Following Tx and the Proportion of Eyes That Achieve D-UCVA of 20/40 or Better as a Function of the Pre-Tx D-UCVA Will Both be Reported.
5 Eyes

Adverse Events

Hyperopia

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

Nancy Lockerman

NTK Enterprises, Inc.

Phone: 831-869-1384

Results disclosure agreements

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