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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.
Enrollment
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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:
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:
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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