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

NCT01028937 | Terminated Results DMC

• 1 other identifier: NTK-1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperopia

Keywords

Hyperopia correction; Laser vision correction; Optimal keratoplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  1 year post-treatment

Secondary Outcomes (1)

• 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

Study Arms (1)

Hyperopia

EXPERIMENTAL

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.

Device: Optimal Keratoplasty

Interventions

Optimal Keratoplasty DEVICE

Laser treatment in 16 spots at treatment energy densities up to 48 mJ per spot

Hyperopia

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Any race
• 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).
• Contacts lens wearers must:
• discontinue use of soft or gas permeable contact lenses at least two weeks prior to baseline measurements or discontinue use of hard or rigid gas permeable contact lenses at least three weeks prior to baseline measurements and
• have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.5 D in either meridian; mires should be regular.
• Patient is willing and able to comply with all pre-treatment and follow-up requirements, including the ability to read English to complete the NEI-RQL questionnaire.
• Patient understands the nature of the procedure, as well as potential\\ risks or limitations of the treatment, and provides informed consent

You may not qualify if:

• 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
• Patients taking amiodarone, isotretinoin and/or sumatriptan
• Patients requiring administration of topical or systemic ophthalmic medications other than the study medications - use of corticosteroids or antimetabolites is specifically contraindicated.
• Patients with a recent history (within one week prior to treatment) of using ophthalmic medications containing preservatives (benzalkonium chloride,etc.) and/or other ocular drugs that are cytotoxic
• Patients who are immunocompromised (by, for example, infectious diseases such as HIV, herpes, etc. and/or by immunosuppressive medications) or who have autoimmune diseases such as lupus, rheumatoid arthritis, etc.
• Patients with diabetes
• Pregnant, planning to be pregnant or lactating women

Sponsors & Collaborators

• NTK Enterprises, Inc.: lead

Study Sites (1)

Laser Vision Medical Associates

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Nancy Lockerman
• Organization: NTK Enterprises, Inc.

nlockerman@opti-k.com

831-869-1384

Study Officials

• Nancy Lockerman

  NTK Enterprises

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 9, 2019
• Results First Posted: May 9, 2019

Record last verified: 2019-04

Locations

US (1)