- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01028937
Hyperopia Correction Using the NTK Optimal Keratoplasty (Opti-K) System
April 18, 2019 updated by: NTK Enterprises, Inc.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Laser Vision Medical Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Laser treatment in 16 spots at treatment energy densities up to 48 mJ per spot
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nancy Lockerman, NTK Enterprises
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (ACTUAL)
January 1, 2018
Study Completion (ACTUAL)
January 1, 2018
Study Registration Dates
First Submitted
December 8, 2009
First Submitted That Met QC Criteria
December 8, 2009
First Posted (ESTIMATE)
December 9, 2009
Study Record Updates
Last Update Posted (ACTUAL)
May 9, 2019
Last Update Submitted That Met QC Criteria
April 18, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTK-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperopia
-
Bausch & Lomb IncorporatedCompletedMyopia and Hyperopia and PresbyopiaUnited States
-
Lee, Steven, M.D.CompletedMyopia, | Hyperopia, | Astigmatism, | Presbyopia, | Eye Strain,
-
Donald O Mutti, OD, PhDCompleted
-
Jaeb Center for Health ResearchNational Eye Institute (NEI); Pediatric Eye Disease Investigator GroupCompleted
-
University Hospital, ToulouseCentre de Référence National du KératocôneTerminated
-
Medipol UniversityCompleted
-
Carl Zeiss Meditec, Inc.Completed
-
University of Sao PauloCompleted
-
Alcon ResearchEnrolling by invitation
Clinical Trials on Optimal Keratoplasty
-
Cornea Research Foundation of AmericaCompletedBullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Iridocorneal Endothelial Syndrome | Posterior Polymorphous DystrophyUnited States
-
Aarhus University HospitalCompletedFuchs' Endothelial Corneal DystrophyDenmark
-
Hospital Oftalmologico de SorocabaUnknown
-
Shahid Beheshti University of Medical SciencesUnknownKeratoconusIran, Islamic Republic of
-
Charite University, Berlin, GermanyUnknownEndothelial Dysfunction | Bullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Iridocorneal Endothelial Syndrome | Posterior Polymorphous DystrophyGermany
-
The S.N. Fyodorov Eye Microsurgery State InstitutionCompleted
-
EDUARD PEDEMONTE-SARRIASCompletedFuchs' Endothelial Dystrophy | Corneal Endothelial Cell LossSpain
-
Oregon Health and Science UniversityNational Eye Institute (NEI); National Institutes of Health (NIH)Terminated
-
Centre Hospitalier Régional Metz-ThionvilleCompletedPseudophakic Bullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Descemet Membrane Endothelial Keratoplasty | Graft DetachmentFrance
-
Netherlands Institute for Innovative Ocular SurgeryAmnitrans Eyebank Rotterdam; Melles CorneaClinic RotterdamCompletedCorneal Dystrophies, HereditaryNetherlands