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

NTK Enterprises, Inc.1 site in 1 country6 target enrollmentDecember 2009

ConditionsHyperopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hyperopia
Sponsor: NTK Enterprises, Inc.
Enrollment: 6
Locations: 1
Primary Endpoint: 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.
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this U.S. Clinical Trial on treatment of sighted eyes is to investigate the safety and effectiveness of optimal keratoplasty (Opti-K™) treatments for hyperopia correction using the NTK Enterprises (NTK) Opti-K System.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

January 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

NTK Enterprises, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Enrollment is limited to subjects who satisfy the following inclusion criteria:
•Male or Female
•Patient is at least 40 years old.
•Patient has bilateral sight with at least one eye with low hyperopia \[with +1.0 to +2.75 D spherical component of manifest refraction, less than or equal to 0.75 D cylindrical component of manifest refraction (minus cylinder format) and manifest refraction, spherical equivalent of +1.0 to +2.5 D\].
•Patient has documented stable refraction defined as a change in baseline MRSE of ≤ 0.5 D for the 12 month period prior to primary Opti-K Tx as verified by consecutive refractions, medical records or prescription history.
•Patient is able to tolerate full cycloplegic refraction while not under cycloplegia.
•Patient has distance uncorrected visual acuity (D-UCVA) less than 20/40 and better than or equal to 20/80 in both eyes.
•Patient has stable D-UCVA as documented by a change of ≤ 1 line of D-UCVA for the 12 month period prior to baseline measurements.
•Patient has distance and near best spectacle corrected visual acuity (D-BSCVA and N-BSCVA) of 20/40 or better in both eyes.
•Patient has normal videokeratography (i.e., without distorted or unclear corneal mires).

Exclusion Criteria

•Patients are not permitted to enroll in the study if they meet any of the following exclusion criteria:
•Patients with latent hyperopia \> 1.0 D (i.e., baseline MRSE and CRSE should not differ by more than 1.0 D)
•Patients with nystagmus
•Patients with previous intraocular or corneal surgery
•Patients with any residual, recurrent or active ocular disease or corneal abnormality, including any of the following: corneal diameter \< 9 mm; central corneal thickness \< 500 µm; mild to severe dry eye disease; uncontrolled uveitis; severe blepharitis; lagophthalmos; glaucoma; intraocular pressure \> 21 mm Hg; cataract; history of uveitis;corneal shape disorders (keratoconus, keratoglobus, pellucid marginal degeneration, significant irregular corneal astigmatism, etc.);history of herpes zoster/simplex keratitis
•Patients with cloudy cornea or cloudy anterior chamber
•Patients with allergy to anesthetics or postoperative medications
•Patients with chronic allergic reactions, tearing and/or ocular irritation
•Patients who are hypersensitive to pain stimulus
•Patients taking systemic medications (NSAIDs, etc.) that affect wound healing

Outcomes

Primary Outcomes

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.

Time Frame: 1 year post-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

Secondary Outcomes

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.(1 year post-treatment)