Clinical Information
Two clinical studies are in progress:
1 - U.S. Clinical Trial (under Investigational Device Exemption IDE #G080183) - This FDA-monitored clinical study is intended to determine the safety and effectiveness of Optimal Keratoplasty (Opti-K®) for Hyperopia Correction. The IDE Initial Study is being completed by two Principal Investigators at two clinical sites:
1A - Harry G. Glen, MD at Advanced Eye Centers, North Dartmouth, MA; E-mail: HG@vrcbahamas.com.
1B - James J. Salz, MD at American Eye Institute, Cedars-Sinai Medical Towers, Los Angeles, CA; E-mail: JS@vrcbahamas.com.
The Indication for Use (IFU) in the U.S. Clinical Trial is:
Indication for Use
The NTK Optimal Keratoplasty (Opti-K®) System/Procedure is indicated for the temporary improvement of distance uncorrected visual acuity (D-UCVA) in patient eyes that have manifest refraction, spherical equivalent (MRSE) = +1.0 to +2.5 D, with ≤ 0.75 D of refractive astigmatism (minus cylinder format) and with D-UCVA < 20/40 but ≥ 20/80. Patients must be ≥ 40 years of age with a documented stability of refraction for the prior 12 months, as demonstrated by a change of ≤ 0.5 D in MRSE. The magnitude of D-UCVA improvement by Opti-K® treatment may diminish over time.
It is planned to obtain a Supplement to the U.S. Clinical Trial in order to enroll patients with emmetropic presbyopia in order to determine the safety and effectiveness of Optimal Keratoplasty (Opti-K®) for near vision improvement.
2 - Nassau Clinical Study - 199 patients are enrolled, including both emmetropic presbyopes and hyperopic presbyopes (with low hyperopia up to ca. +3 D); follow-up extends to 2 years post-Tx for the earliest patient groups. K. Jonathan Rodgers, FRCS(C), DABO is the Principal Investigator in the Nassau Clinical Study.
Abstracts reporting clinical outcomes for two initial groups of Nassau Clinical Study patients are available in the Download section. These initial groups include all patients who received primary Txs using Tx pattern #1. Other patients received primary Tx using improved Tx patterns and procedures; their outcomes will be reported after longer follow-up results are available.
Both emmetropic and hyperopic patients (spanning a range of MRSE from -0.25 D to +3.0 D) have already been treated in Nassau, The Bahamas. Optimal Keratoplasty (Opti-K®) Txs are now available to patients who are not enrolled in the Nassau Clinical Study but who meet the Inclusion/Exclusion Criteria listed below. Almost all patients are now being treated in stages (to ensure comfort and complete epithelial protection and to prevent overcorrection); hence, patients should anticipate that at least two Tx a month apart will be used to achieve best distance and near vision improvement.
Opti-K® Inclusion/Exclusion Criteria for Overcoming Presbyopia in emmetropic Presbyopes:
Manifest Refraction, Spherical Equivalent (MRSE) = -0.25 D to +0.75 D; 0.75 D or less cylinder (minus format)
| Cylinder | Sphere | -0.25 | 0.00 | +0.25 | +0.50 | +0.75 | +1.00 |
|---|---|---|---|---|---|---|---|
| plano | x | x | x | x | x | ||
| -0.25 | x | x | x | x | |||
| -0.50 | x | x | x | x | x | ||
| -0.75 | x | x | x | x |
Inclusion criteria:
- Both eyes 20/32 or better for corrected distance visual acuity (CDVA) - this is probably good to avoid treating eyes with uncorrectable and/or progressive problems
- Age ≥ 40 years old
- Signs and/or symptoms of presbyopia such as inadequate reading vision
Contraindications:
- Keratoconus or other abnormal cornea
- Significant central corneal scarring or corneal disease
- Open Angle Glaucoma
- Nystagmus
- Very irregular and/or decentered pupils
- Moderate to severe ocular surface disease (including dry eye, severe blepharitis,...) and/or chronic allergic reactions and/or occupational irritants; medications such as Lotemax® and Restatis® may be effective in reducing ocular surface disease
- Unrealistic expectations
Pre-treatment assessment:
- Occupation (for example, professional truck drivers who may be affected by any amount of night vision disturbance)
- Uncorrected distance and near visual acuities (UDVA and UNVA)
- Corrected distance and near visual acuities (CDVA and CNVA)
- Refraction OU
- Scotopic pupil size and location
- Pachymetry - to detect cornea irregularities such as keratectasia
- Corneal topography - to detect cornea irregularities such as keratectasia
Counseling:
- There may be a myopic shift immediately after treatment, which resolves.
- Early presbyopes may experience a shorter working distance after treatment, which will improve with time.
- Good lighting of reading material is essential.
- Mean gain in near vision is 4 lines of near vision, e.g., from J5 to J1+ on a Jaeger chart. The target is good functional distance and near vision; near vision improvement is temporary but repeatable.
Aftercare:
Opti-K® Inclusion/Exclusion Criteria for Correcting Hyperopic Presbyopia :
Manifest Refraction, Spherical Equivalent (MRSE) = +0.88 D to + 3.0 D; 0.75 D or less cylinder (minus format)
| Cylinder | Sphere | +1.00 | +1.25 | +1.50 | +1.75 | +2.00 | +2.25 | +2.50 | +2.75 | +3.00 | +3.25 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| plano | x | x | x | x | x | x | x | x | x | ||
| -0.25 | x | x | x | x | x | x | x | x | x | ||
| -0.50 | x | x | x | x | x | x | x | x | x | ||
| -0.75 | x | x | x | x | x | x | x | x | x |
Inclusion criteria:
- Both eyes 20/32 or better for corrected distance visual acuity (CDVA) - this is probably good to avoid treating eyes with uncorrectable and/or progressive problems
- Age ≥ 40 years old
- Signs and/or symptoms of hyperopia and/or presbyopia such as inadequate reading vision
Contraindications:
- Keratoconus or other abnormal cornea
- Significant central corneal scarring or corneal disease
- Open angle glaucoma
- Nystagmus
- Very irregular and/or decentered pupils
- Moderate to severe ocular surface disease (including dry eye, severe blepharitis,...) and/or chronic allergic reactions and/or occupational irritants; medications such as Lotemax® and Restatis® may be effective in reducing ocular surface disease
- Unrealistic expectations
Pre-treatment assessment:
- Occupation (for example, professional truck drivers who may be affected by any amount of night vision disturbance)
- Uncorrected distance and near visual acuities (UDVA and UNVA)
- Corrected distance and near visual acuities (CDVA and CNVA)
- Refraction OU
- Scotopic pupil size and location
- Pachymetry - to detect cornea irregularities such as keratectasia
- Corneal topography - to detect cornea irregularities such as keratectasia
Counseling:
- Two treatments are essential for larger amounts of hyperopia.
- Early presbyopes may experience a shorter working distance after treatment, which will improve with time.
- Good lighting of reading material is essential.
- Mean gain in distance vision is 4 lines of UDVA, e.g., from 20/50 to 20/20. The target is good functional distance vision; near vision will also improve.
Aftercare:
In the United States, Opti-K® has not been cleared or approved for use by the U.S. Food and Drug Administration for the general population. In the United States, Opti- K® is only available for investigational use to treat patients enrolled in the U.S. Clinical Trial.