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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by NTK Enterprises, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
NTK Enterprises, Inc.
ClinicalTrials.gov Identifier:
NCT01028937
First received: December 8, 2009
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Hyperopia
Device: Optimal Keratoplasty

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperopia Correction Using the NTK Optimal Keratoplasty (Opti-K) System

Further study details as provided by NTK Enterprises, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Optimal Keratoplasty
Laser treatment in 16 spots at treatment energy densities up to 48 mJ per spot

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrollment is limited to subjects who satisfy the following inclusion criteria:

    • 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:

      1. 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
      2. 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

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
    • 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
    • Patients with unusual hormonal status due to, for example, hormone replacement therapy
    • Patients who have taken or who plan to take oral contraceptives within one year prior to, or following, treatment
    • Patients with unrealistic expectations
    • Patients participating in other ophthalmic clinical trials during this clinical investigation
    • Persons who, in the determination of the investigator, are not competent to understand the procedure or the actions asked of them as research subjects
    • Persons who may not be able to complete the requirements of returning to the investigator's clinic over the period of the study, or who may be difficult to locate or contact on short notice. This does not preclude vacations or travel.
    • Persons who cannot achieve corneal applanation using the SAWSR device or cannot tolerate application of the SAWSR device or who cannot remain motionless for at least 5 seconds after verifying proper SAWSR mounting.
    • Patients who are likely to be exposed to high levels of ultraviolet radiation(from sunlight, tanning lights, etc.) without protective eyewear during the one year period following Opti-K treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028937

Contacts
Contact: Michael Berry, PhD 831-869-1384 mberry@ntkok.com
Contact: Harry Glen, MD 561-252-0946 1lancer@bellsouth.net

Locations
United States, California
American Eye Institute Recruiting
Los Angeles, California, United States, 90048
Contact: James J Salz, MD    310-652-1133    drjjsalz@gmail.com   
Contact: Ezra Maguen, MD    310-652-1133    Ezra.Maguen@cshs.org   
Principal Investigator: James J Salz, MD         
Sub-Investigator: Ezra Maguen, MD         
United States, Massachusetts
Advanced Eye Centers Recruiting
North Dartmouth, Massachusetts, United States, 02747
Contact: Harry Glen, MD    561-252-0946    1lancer@bellsouth.net   
Contact: Paul Abrantes, BS    508-995-3060    pabrantes@2020aec.com   
Principal Investigator: Harry Glen, MD         
Sponsors and Collaborators
NTK Enterprises, Inc.
Investigators
Study Director: Michael Berry, PhD NTK Enterprises
Study Director: Michael Berry, PhD NTK Enterprises, Inc.
  More Information

No publications provided

Responsible Party: Michael Berry, PhD - Director of Research, NTK Enterprises
ClinicalTrials.gov Identifier: NCT01028937     History of Changes
Other Study ID Numbers: NTK-1
Study First Received: December 8, 2009
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by NTK Enterprises, Inc.:
Hyperopia correction
Laser vision correction
Optimal keratoplasty

Additional relevant MeSH terms:
Hyperopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 27, 2014