Conductive Keratoplasty Hyperopia and Presbyopia

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Background

Although nonsurgical correction (ie, glasses, contact lenses) for patients with low-level hyperopia and presbyopia has been widely successful throughout the world, the surgical correctional procedures have been somewhat less accepted. (See History of the Procedure.) Conductive keratoplasty (CK), an advanced method for vision correction using controlled-release radiofrequency energy to gently reshape the cornea and to provide long-lasting vision correction, is now available for these patients. See the video below for an introduction to conductive keratoplasty.



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Video introduction to conductive keratoplasty.

 

History of the Procedure

Laser and laserlike surgical procedures for the correction of hyperopia have a checkered history.[1, 2, 3, 4, 5, 6] For this article, the discussion is limited to CK.

The history of CK for hyperopia began with Svyatoslav Fyodorov, MD, the inventor of radial keratotomy (RK). Fyodorov inserted a hot needle (nickel-chromium probe) at the peripheral cornea to induce shrinkage. This procedure was called hot needle keratoplasty; others referred to it as hot needle in the eye or HNE. Fyodorov encountered problems with consistency and maintenance of the temperature because the temperature (heated to as high as 600° C) went down as the hot needle entered the cornea (to a desired depth of up to 90% of corneal thickness). A scorching sound was produced each time the needle was applied on the cornea. The procedure resulted in an uneven application of heat, with the external cornea receiving more heat than the inner cornea.

Summit Laser then introduced its holmium:YAG laser, first successfully used by Theo Seiler, MD, in 1990 for contact laser thermal keratoplasty (LTK) for the correction of hyperopia of up to 5 diopters (D), which also eventually failed.

In 1995, Sunrise Technologies introduced its noncontact holmium laser (Hyperion LTK System) for hyperopic correction via LTK. The problems that beset this particular technology were also related to the regression associated with the unequal distribution of energy from the base to the apex.

Nonholmium types (CO2 lasers and diode lasers) of laser thermokeratoplasty options appeared in the market, also resulting in positive but transient effects.

Early attempts with hyperopic photorefractive keratectomy (HPRK) were besieged by haze and regression.

The aforementioned procedures were successful in correcting some degree of hyperopia; however, long-term stability, vision quality, and patient comfort were not properly addressed. They were all instrumental as building blocks for the success of hyperopic laser in situ keratomileusis (LASIK), which currently provides excellent outcomes for low levels of hyperopia; low levels of hyperopia are classified as +3.00 D in the United States and up to +5.00 D in Canada.[7, 8, 9]

Mendez then discovered CK. This revolutionary procedure presents convincing advantages over hyperopic LASIK and hyperopic correction via LTK.[10] CK uses high radiofrequency energy that is delivered with a thin metal tip in concentric rings of multiple spots around the corneal periphery, shrinking collagen and steepening the central cornea. Refractec manufactures and markets this technology.[11, 12, 13, 14]

See related CME at LASIK Mostly Effective in Long-Term for Myopia of More Than -10 Diopter.

Problem

The central problem in the correction of hyperopia and presbyopia is the pressing challenge of steepening the central cornea.[15]

Current treatment modalities include excimer laser ablation of the corneal periphery via either photorefractive keratoplasty (PRK) or LASIK and shrinkage of collagen in a circular pattern in the corneal periphery (eg, LTK).[16] Hyperopic LASIK has been described as widely successful for low levels of hyperopia; however, the risk of flap-related complications cannot be overlooked. Thermal keratoplasty alters corneal curvature by heating the stromal tissue and causing the shrinkage of collagen. An optimal collagen shrinkage profile is currently acceptable. Previous experience has shown that too low of a heat causes minimal effect, while excessive heat causes remodeling and regression of effect. Two methods of collagen shrinkage are available: application of laser energy (ie, LTK) and application of radiofrequency energy (ie, CK).[17]

Hyperopia

The Food and Drug Administration (FDA) Phase III clinical trials for CK included the following investigators: Asbell, McDonald, Maloney, Davidorf, Hersh, Manche, and Durrie.[18] The study was a prospective multicenter clinical trial to evaluate both the safety and the effectiveness of the ViewPoint CK system for the correction of hyperopia using the CK procedure. The study design was consistent with FDA guidance for refractive surgery lasers and draft American National Standards Institute (ANSI) guidance regarding laser systems for corneal reshaping.

The aim of the study was for a full correction of spherical hyperopia (ie, target of plano). All the treatments were based on preoperative cycloplegic refraction spherical equivalent (CRSE). Eligible patients for the study included those in the range of +0.75 D to +3.25 D of spherical hyperopia, with -0.75 D or less of refractive cylinder, yielding +0.75 D to +3.00 D cycloplegic spherical equivalent.

The effective parameters included improvement in uncorrected visual acuity (UCVA), predictability, stability, and patient satisfaction.

Presbyopia

The FDA Phase III clinical trials for presbyopic application of CK included the following investigators: McDonald, Durrie, Asbell, Maloney, and Nichamin.[19] The study was a prospective multicenter clinical trial to evaluate CK for the treatment of presbyopic symptoms in emmetropic and hyperopic eyes.

Epidemiology

Frequency

Although numerous figures are reported in publications, the exact number of hyperopes in the world is unknown. Generally, hyperopia is believed to affect millions of persons in the United States and hundreds of millions of individuals around the world.

Of those individuals older than 50 years, 100% of them need corrective lenses for presbyopia.

Etiology

Errors in refraction may be inherited, and hyperopia may run in families. Presbyopia is a natural part of the aging process and affects everyone.

Pathophysiology

In CK, a controlled release of radiofrequency energy is delivered intrastromally via a probe tip (450 µm X 90 µm). Impedance of the corneal tissue results in a thermal effect.[20, 21] Thermal profile is homogeneous to approximately 80% of the depth of the cornea. The CK footprint has an average width of 405 µm and an average depth of 509 µm, as measured with ultrasonic biomicroscopy.

Presentation

At some point, most, if not all, patients with hyperopia complain of a reduction in vision. The degree of blur depends on the amount of refractive error present. Both near vision and distance vision may be affected. Age may affect the reduction in visual performance. Patients with mild hyperopia, who function well prior to the presbyopic years, begin to experience difficulty with near work once their age approaches 40 years. Visual improvement is excellent with appropriate correction.

Indications

Hyperopic indications

The basis for the initiation of CK as a surgical procedure includes hyperopia. Hyperopia, commonly referred to as farsightedness, is an error of refraction (EOR) in which an individual may not have any difficulty seeing objects that are distant but may have problems focusing on objects that are near. In some instances, farsighted individuals can see all objects clearly, but they notice the need to strain the eyes, albeit unnecessarily, to maintain focus.

This type of EOR occurs when the eyeball is too short or when the cornea is too flat. In hyperopia, rays of light focus behind the retina instead of on it. This results in poor vision because the focus of light is not directly on the retina where it should be for normal vision. This anatomical structure induces a constant physiologic attempt to make up for the problem and to focus images. Symptoms of hyperopia involve asthenopia, which can include eyestrain, blurred vision, or headache (especially when reading or at the end of the day). These symptoms can increase over time.

Farsightedness (hyperopia) is often confused with presbyopia, which is a normal development of the aging process. Presbyopia occurs when the lens inside the eye loses flexibility, thereby preventing accurate focusing on nearby objects. This condition is common in individuals by the age of 40 years, and all persons older than 50 years experience presbyopia. People with this condition may experience eye strain/fatigue when reading in poor lighting conditions or at the end of the day, have trouble (slow) in changing focus from distance to near, or need to constantly reposition (move away) reading material in an attempt to find the correct focus.[22, 23]

CK hyperopic indications for use, as approved by the FDA, are as follows[18] :

Presbyopic indications

FDA supplemental approval of Refractec ViewPoint® CK System is for the temporary induction of myopia (-1.00 D to -2.00 D) to improve near vision in the nondominant eye of presbyopic hyperopes or presbyopic emmetropes, as follows[19] :

Other Indications

In 2015, Sy et al reported that combined astigmatic keratotomy and conductive keratoplasty is safe and effective for correcting high corneal astigmatism after surgery or trauma.[24]

CK is an elective procedure with the alternatives including, but not limited to, the following:

Additional selection criteria

Suggested additional initial patient selection criteria for CK are as follows:

Relevant Anatomy

In hyperopia, the axial length (measurement of the most anterior part of the cornea to the most posterior part of the sclera) of the eyeball is generally shorter than normal and/or the corneal diopteric strength is weaker (flatter curvature).

A transparent avascular tissue, the cornea is continuous with the opaque sclera and the semitransparent conjunctiva. The cornea is covered by tear film on its anterior surface and bathed by aqueous humor on its posterior surface.

In adults, the cornea measures 11-12 mm horizontally and 9-11 mm vertically. The average corneal thickness is 0.5 mm (500 µm) centrally and 0.7 mm (700 µm) peripherally.

Contraindications

Patients must meet the inclusion criteria to be considered a good candidate for CK. A few relative contraindications (exclusion criteria) exist for CK, as follows:

Patient Education

Conductive keratoplasty is a safe procedure that inevitably regresses. Regression is usually complete at around 2 years after surgery. Because of this, conductive keratoplasty is no longer considered the procedure of choice for hyperopia or presbyopia management.[28, 29, 30]

Imaging Studies

Corneal topography development provides surgeons with effortlessly understood color-coded maps of corneal curvature, in addition to quantitative indexes of irregular astigmatism that correlate with potential visual acuity.[31] Modern instrumentation produces a videokeratograph (generally a color-coded contour map).[14] The use of keratography in preoperative and postoperative evaluation of all refractive surgery patients is valuable. Different manufacturers use different methods (eg, Placido, 40 scanned slits, combination Placido and 40 scanned slits, phase modified laser holography, raster stereography).

The pachymeter (eg, optical, ultrasonic) is used to measure corneal thickness. Accurate determination of corneal thickness preoperatively allows the surgeon to set the depth of incision to two thirds of the measured result. Orbscan II by Orbtek uses both 40 scanned slits and Placido methods to provide data on anterior and posterior corneal curvature and corneal thickness.

Ultrasonic biomicroscopy is used to measure corneal thickness (where available). Typically, it is used in clinical studies.

Medical Therapy

Medical therapy is limited to broad-spectrum topical antibiotics and corticosteroids for uncomplicated cases (see Postoperative details).

Surgical Therapy

See Intraoperative details for the surgical procedure.

Preoperative Details

The procedure for CK can be performed with a local (topical) anesthetic in the form of eye drops to numb the eye. Patients who are nervous and/or have a high level of anxiety may be given a mild sedative to assist them in relaxing for the procedure.

The operative field is prepared, and the patient is prepared in the usual sterile fashion for ophthalmic surgery. A lid speculum, as shown below, is used for globe exposure.



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Hyperopia, conductive keratoplasty. Speculums. Published with permission from Refractec.

This procedure may be performed inside the clinic.

Intraoperative Details

After appropriately preparing the patient, a lid speculum is used to hold open the eye during the CK procedure; it also serves as a return path for the radiofrequency energy applied via the instrument. CK is performed using a pen-shaped instrument to apply controlled radiofrequency energy in a ring pattern on the cornea. In performing CK, the conductive tip should be placed perpendicularly to the corneal surface prior to activation. This placement of the conductive tip ensures appropriate application of the conduction marks. The procedure is considered painless and typically requires only a few minutes (approximately 5 min) to perform. See the images below.



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ViewPoint conductive keratoplasty device. Published with permission from Refractec.



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Hyperopia, conductive keratoplasty. Suture. Published with permission from Refractec.



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Hyperopia, conductive keratoplasty. Corneal markings. Published with permission from Refractec.



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Hyperopia, conductive keratoplasty. ViewPoint with radiation. Published with permission from Refractec.



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Hyperopia, conductive keratoplasty. Change in corneal curvature. Published with permission from Refractec.

LightTouch technique

LightTouch is a corneal compression technique in which surgeons should apply minimal pressure to the cornea. The application of the tip is similar to the initial procedure identified above, except that after the tip is completely implanted into the cornea, it is retracted slightly until there is minimal to no indentation of the cornea, followed by application of the radiofrequency energy. See the images below.



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NearVision conductive keratoplasty with LightTouch technique.



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Conductive keratoplasty conventional pressure technique.

Postoperative Details

Following the procedure, the lid speculum is removed. Postoperatively, antibiotic-corticosteroid combination drops and/or ointment are used. Antibiotic-corticosteroid combination drops are used 4 times daily for 1 week. The eye may be covered overnight with a shield.

Follow-up

Certain precautions should be taken following the CK procedure and are similar to those that are required with any other type of vision procedure where the cornea is altered.

Patients should take the following precautions for at least 1 week after surgery:

Patients should avoid vigorously rubbing the eyes for 2 weeks after the surgical procedure.

Patients are seen postoperatively on day 1; week 1; and months 1, 3, 6, and 12. Vision begins to improve within a week's time. The surgeon should monitor patients for postoperative complications; an observation timeline is outlined in Complications.

For patient education resources, see the Eye and Vision Center, as well as Vision Correction Surgery and Contact Lenses.

Complications

See the list below:

Outcome and Prognosis

In 2001, McDonald and Maloney presented the interim results of the FDA Phase III clinical trial during the American Society of Cataract and Refractive Surgery (ASCRS) meeting in San Diego. Maloney reported that at 9-month follow-up, the UCVA was found to be 20/20 or better in 60% of the eyes treated and 20/40 or better in 96% of the eyes treated. In addition, 60% of the eyes were within 0.5 D of planned correction, whereas 80% of the eyes were within 1 D of planned correction. Maloney reported the absence of adverse events or complications after 9 months. McDonald reported that at 12-month follow-up, the UCVA was found to be 20/20 for 51% of the eyes treated, 20/25 for 73% of the eyes treated, and 20/40 or better for 91% of the eyes treated.[18, 44, 45, 19, 34, 36, 15, 46, 47, 48, 49, 50, 51, 52]

In 2004, McDonald, Durrie, Asbell, et al, published the 6-month results of a 1-year clinical trial evaluating CK for the treatment of presbyopic symptoms in emmetropic and hyperopic eyes.[19]

Regression

Future and Controversies

Conductive keratoplasty is demonstrated to be safe for the treatment of presbyopia in post-LASIK patients as well as in non-LASIK patients, although longer observation in terms of factors affecting predictability is suggested. It is understood that LASIK affects the biomechanical properties and strength of the cornea, and this may be the reason for the lesser, albeit statistically insignificant, predictability.[58]

Topography-guided conductive keratoplasty may be effective in reshaping corneal configuration in eyes with keratoconus. Although the reported follow-up time is short, it theoretically may avoid or delay corneal transplantation in some cases.[59, 60]

Studies have been conducted for the safe application of conductive keratoplasty for astigmatism.[35, 61, 62, 63] Other surgical methods for the correction of hyperopia include phakic intraocular lenses (implantable contact lenses). Bifocal intraocular lenses and scleral-relaxing incision with collagen plug implantation are among the other surgical methods for the correction of presbyopia.

Author

Manolette R Roque, MD, MBA, FPAO, Section Chief, Ocular Immunology and Uveitis, Department of Ophthalmology, Asian Hospital and Medical Center; Section Chief, Ocular Immunology and Uveitis, International Eye Institute, St Luke's Medical Center Global City; Senior Eye Surgeon, The LASIK Surgery Clinic; Director, AMC Eye Center, Alabang Medical Center

Disclosure: Nothing to disclose.

Coauthor(s)

Barbara L Roque, MD, DPBO, FPAO, Senior Partner, Roque Eye Clinic; Chief of Service, Pediatric Ophthalmology and Strabismus Section, Department of Ophthalmology, Asian Hospital and Medical Center; Active Consultant Staff, International Eye Institute, St Luke's Medical Center Global City

Disclosure: Nothing to disclose.

Roberto Pineda, II, MD, Director, Refractive Surgery Service, Massachusetts Eye and Ear Infirmary; Associate Professor of Ophthalmology, Harvard Medical School

Disclosure: Received consulting fee from Amgen for review panel membership; Received consulting fee from Genzyme?Sanofi for review panel membership; Received consulting fee from Novartis for consulting; Received consulting fee from Beaver-Visitec for consulting.

Ruben Limbonsiong, MD,

Disclosure: Nothing to disclose.

Specialty Editors

Francisco Talavera, PharmD, PhD, Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Received salary from Medscape for employment. for: Medscape.

J James Rowsey, MD, Former Director of Corneal Services, St Luke's Cataract and Laser Institute

Disclosure: Nothing to disclose.

Chief Editor

Hampton Roy, Sr, MD, Associate Clinical Professor, Department of Ophthalmology, University of Arkansas for Medical Sciences

Disclosure: Nothing to disclose.

Additional Contributors

Daniel S Durrie, MD, Director, Department of Ophthalmology, Division of Refractive Surgery, University of Kansas Medical Center

Disclosure: Received grant/research funds from Alcon Labs for independent contractor; Received grant/research funds from Abbott Medical Optics for independent contractor; Received ownership interest from Acufocus for consulting; Received ownership interest from WaveTec for consulting; Received grant/research funds from Topcon for independent contractor; Received grant/research funds from Avedro for independent contractor; Received grant/research funds from ReVitalVision for independent contractor.

Acknowledgements

The authors and editors of Medscape Reference gratefully acknowledge the assistance of Ryan I Huffman, MD, with the literature review and referencing for this article.

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Video introduction to conductive keratoplasty.

Hyperopia, conductive keratoplasty. Speculums. Published with permission from Refractec.

ViewPoint conductive keratoplasty device. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. Suture. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. Corneal markings. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. ViewPoint with radiation. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. Change in corneal curvature. Published with permission from Refractec.

NearVision conductive keratoplasty with LightTouch technique.

Conductive keratoplasty conventional pressure technique.

ViewPoint conductive keratoplasty device. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. Speculums. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. Suture. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. Corneal markings. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. ViewPoint with radiation. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. Change in corneal curvature. Published with permission from Refractec.

Hyperopia, conductive keratoplasty. Refractec, 1 hour. Published with permission from Refractec.

Video introduction to conductive keratoplasty.

Conductive keratoplasty conventional pressure technique.

NearVision conductive keratoplasty with LightTouch technique.