Emanuel S. Rosen

Format for reporting refractive surgical data

W ith the proliferation of refractive surgical procedures, it is essential that refractive surgical data be reported in a clear and consistent manner. 1,2 Regrettably, current data presentation is somewhat haphazard, and key data may be incompletely or unclearly described. To assist readers and authors alike, the editors of this journal wish to establish a standard format for data presentation that will be incorporated into the Instructions for Authors. The adoption of a standard format should also serve as a guide for developing a study design that will capture pertinent data in a systematic manner. We describe the important structural and reporting elements of refractive surgical articles. Essentially all these elements are mandatory, although some could be omitted if not pertinent to the particular study.

Cataract development after implantationof the Staar Collamer posterior chamber phakic lens

Implantation of a posterior chamber phakic intraocular lens is an effective refractive procedure with a good safety record in the short-term follow-ups reported in the literature. Cataract formation is a potential complication of the procedure. Two patients developed lens opacities in 3 eyes after the procedure was performed for myopic astigmatism. The possible causes are discussed. This is not a dangerous complication as cataract extraction is easily achieved if necessary. However, it is undesirable and further research is required to assess the long-term incidence, causes, and ways to prevent its occurrence.

Standardized graphs and terms for refractive surgery results.

A critical element of peer-reviewed publication is clear communication to the reader and the ophthalmic and medical community. Refractive surgery has the luxury of multiple procedures with multiple outcome parameters that are relevant to clinicians, researchers, and, of course, patients. This diversity introduces complexity for the reader in evaluating and comparing various procedures as they are applied to various patient populations. For over a decade, the editors of the Journal of Refractive Surgery (JRS) and the Journal of Cataract & Refractive Surgery (JCRS) have advocated a minimally acceptable level of standardization in reporting results of refractive surgical procedures.1,2 This has culminated in a set of criteria that include basic elements that must be reported in every manuscript. To further this goal of clear reporting, the editors of JCRS, JRS, and Cornea would like to announce their collaboration in standardizing two aspects of data reporting in refractive surgery.

Efficacy and safety of multifocal intraocular lenses following cataract and refractive lens exchange: Metaanalysis of peer-reviewed publications

&NA; We performed a metaanlysis of peer‐reviewed studies involving implantation of a multifocal intraocular lens (IOL) in presbyopic patients with cataract or having refractive lens exchange (RLE). Previous reviews have considered the use of multifocal IOLs after cataract surgery but not after RLE, whereas greater insight might be gained from examining the full range of studies. Selected studies were examined to collate outcomes with monocular and binocular uncorrected distance, intermediate, and near visual acuity; spectacle independence; contrast sensitivity; visual symptoms; adverse events; and patient satisfaction. In 8797 eyes, the mean postoperative monocular uncorrected distance visual acuity (UDVA) was 0.05 logMAR ± 0.006 (SD) (Snellen equivalent 20/20−3). In 6334 patients, the mean binocular UDVA was 0.04 ± 0.00 logMAR (Snellen equivalent 20/20−2), with a mean spectacle independence of 80.1%. Monocular mean UDVA did not differ significantly between those who had a cataract procedure and those who had an RLE procedure. Neural adaptation to multifocality may vary among patients. Financial Disclosure Dr. Alió is a clinical research investigator for Hanita Lenses, Carl Zeiss Meditec AG, Topcon Medical Systems, Inc., Oculentis GmbH, and Akkolens International BV. Dr. Dell is a consultant to Bausch & Lomb and Abbott Medical Optics, Inc. Dr. Slade is a consultant to Alcon Surgical, Inc., Carl Zeiss Meditec AG, and Bausch & Lomb. None of the authors has a financial or proprietary interest in any material or method mentioned.

Is 2% hydroxypropylmethylcellulose a safe solution for intraoperative clinical applications?

ABSTRACT We examined 2% hydroxypropylmethylcellulose prepared for clinical intraocular surgical procedures in various laboratories. Each sample contained a variety of particulate debris of botanical origin, although in varying amounts. The identified material was also seen in a sample of the raw material from which all the clinical material had been prepared. Our conclusion is that filtration methods, which are the physical methods used to purify the product, are at worst ineffective and at best inadequate. Until proper laboratory and clinical studies confirm an acceptable level of adverse reactions, we recommend that this material not be used clinically.

Tracker-assisted Laser in situ keratomileusis for myopia using the Autonomous scanning and tracking laser 12-month results

OBJECTIVE To determine the safety, efficacy, and predictability of the Autonomous scanning and tracking laser for the correction of myopia and myopic astigmatism with laser in situ keratomileusis (LASIK) procedure. DESIGN Retrospective, noncomparative case series. PARTICIPANTS The first 129 consecutive eyes with up to -13.00 diopters (D) of myopia and -5.00 D of astigmatism. INTERVENTION Myopic tracker-assisted LASIK (T-LASIK) using the Autonomous Laser (Alcon Summit Autonomous, Waltham, MA) and Hansatome microkeratome (Bausch & Lomb Surgical, Bracknell, England). MAIN OUTCOME MEASURES Uncorrected visual acuity (UCVA), manifest spherical equivalent (MSE), best spectacle-corrected visual acuity (BSCVA), and complications were studied. RESULTS At 12 months, the mean MSE was -0.02 +/- 1.01 D, with 79.1% of eyes within 0.5 D and 89.9% of eyes within 1 D of the intended correction. UCVA was 20/20 or better in 71.4%, 20/25 or better in 78.5%, and 20/40 or better in 92.8% of eyes. Two eyes (1.6%) lost 2 lines and five eyes (3.8%) gained 2 lines of BSCVA. Sixteen eyes (12.4%) required retreatment to correct residual myopia or astigmatism. After retreatment, 14 of 16 eyes were within 0.5 D of emmetropia. Nine eyes (6.9%) had minor flap complications; two eyes (1.6%) had grade 2 diffuse lamellar keratitis, of which one eye had associated peripheral flap melt. One eye showed slight decentration; this eye was rolling throughout the procedure. All eyes had some dryness, with 10% severe enough to require temporary punctual occlusion with plugs. CONCLUSIONS T-LASIK for myopic astigmatism with the Autonomous Laser is relatively safe, effective, and predictable. The tracker seems to be effective, and the complications are relatively few. Retreatment rates are acceptable and can be performed safely and effectively to improve visual outcome. The outcomes are comparable with other published data.

Correction of pseudophakic anisometropia with the Staar Collamer implantable contact lens

Purpose: To assess the role of the Staar Surgical implantable contact lens (ICL) for the correction of pseudophakic anisometropia. Setting: Oxford Eye Hospital, Oxford, and Rosen Eye Center, Alexandra Hospital, Manchester, United Kingdom. Methods: Six patients with pseudophakic anisometropia ranging from 2.0 to 7.9 diopters (D) (mean 4.4 D) had ICL implantation as an alternative to intraocular lens (IOL) exchange or conventional piggyback IOLs. Results: All patients had a reduction in anisometropia to asymptomatic levels. The mean reduction was 3.15 D. No patient experienced adverse effects. Conclusions: The implantable contact lens offers an alternative approach to the management of pseudophakic anisometropia that avoids some of the risks associated with IOL exchange, corneal refractive surgery, and conventional piggyback IOLs.

Risk management in refractive lens exchange

Healthy eyes with excellent best corrected visual acuity (BCVA) present a different prospect for surgical intervention than visually impaired eyes, where the aim of surgery is to restore good vision. Accordingly, the issue of consent is and should be more stringent. In particular, sight-threatening complications require discussion and evidence regarding the scale of risk, however small. As refractive lens exchange (RLE) becomes more popular and effective for the permanent relief of ametropia, the accumulating evidence for risk assessment is pertinent. The proposed intervention of RLE requires the surgeon to identify for the patient the adverse outcomes that may result, eg, side effects, complications, and failure to achieve the desired aim, while noting the variation in outcomes of various degrees.

Opposite clear corneal incisions.

The mark of a novel but potentially enduring innovation is “why didn’t I think of that?” In their article in this issue, Lever and Dahan make such a mark in the advanced management of pre-existing astigmatism, applicable to cataract refractive surgery, refractive lensectomy, and phakic intraocular lens (IOL) surgery. During the modern evolution of the refractive aspects of lenticular surgery, through the periods of intracapsular cataract extraction (ICCE) and larger incision extracapsular cataract extraction (ECCE), we learned that the corneal meridian on which the extended incisions were based flattened during the healing process. Pathologically, large incisions heal with added tissue, with consequent extension of the radius of curvature of that central meridian. The invariable consequence of that era of surgery was against-the-rule (ATR) astigmatism of a significant degree. Corneal topography then added another dimension in the comprehension of changes in corneal shape. This was especially applicable as algorithms soon provided information about the more peripheral cornea and surgically induced changes therein, which could affect the optical zone of the cornea. Incisions for lenticular surgery reverted to the cornea because small incisions became practicable without enlargement to accommodate foldable IOLs. As small enough incisions did not induce astigmatic change, the issue of managing pre-existing astigmatism became especially relevant. Clear corneal incisions, whether temporal or oblique, do not affect the shape of the cornea’s optical zone if correctly engineered and less than 3.0 mm 6 10%. How, then, should pre-existing astigmatism be eliminated? There were 2 favored options; either center the clear corneal incision on the steep corneal meridian and extend its form by an arcuate component or, using a “standard clear corneal incision,” perform limbal or clear corneal arcuate incisions across the steep corneal meridian. Both systems are effective, especially the latter, if paired incisions are used. An alternative method to isolate the optical zone of the cornea has not achieved universal acceptance. Corneal topographic maps after clear corneal incisions reveal that localized flattening of the cornea central to the incisions invariably and understandably occurs. The wider the incision, the greater the effect. Thus, if 3.0, 4.0, 5.0, and 6.0 mm clear corneal incisions are compared topographically, as the incisions extend so does the flattening effect to produce V-shaped steep hemimeridia extending on both sides of the incision. The shorter the incision, the more localized the effect. Thus, an incision of less than 3.0 mm will not influence the shape of the optical zone of the cornea. Taking this process to its logical conclusion, a 12.0 to 14.0 mm incision as used for ICCE/ECCE will produce ATR astigmatism with a flat “whole” meridian centered on the incision and a steep meridian at 90 degrees to the flat meridian. A clear corneal incision of 4.0 to 5.0 mm will create hemimeridional change. If, however, the clear corneal incision is repeated diametrically opposite the initial incision and if both incisions are placed on the steep meridian, symmetry will occur in the flattening of the steep meridian. This is the concept of opposite clear corneal incisions (OCCI) proposed by Lever and Dahan, and it really states the obvious. They are to be applauded for bringing the concept to our attention. The OCCI technique is simple to perform and can be varied according to the astigmatic requirement. As with other incisional techniques, there is an element of art as well as science for we all stamp our individuality on the same type of incision. It is the principle that is important. Technically, the technique requires a stable anterior chamber, best achieved with the new generation of ophthalmic viscosurgical devices whose dispersive characteristics add to their cohesive nature to ensure that the chamber is stable during the incision process. Lever and Dahan, on the other hand, favor the anterior chamber maintainer to achieve the same end. We also have to remember that incisions in themselves are subject to from the editor

Cataract surgery is refractive surgery

The evolution of modern cataract surgery from a time when the cataract could be removed through a small incision (astigmatically neutral) to the time when intraocular lens (IOL) manufacture caught up with the small-incision parameters was the true beginning of cataract refractive surgery, which is the aim of every cataract surgical procedure. Variation in IOL dioptric power is used to alter the refraction of the eye having surgery. Relaxing incisions and toric IOLs are used to fine tune the refractive outcome. Therefore, the obvious question arises:What additional refractive elements are used by adding femtosecond incisions, capsulorhexis, and nucleus fragmentation? The current hype for laser-assisted cataract surgery has included the frequently used term laser-assisted refractive cataract surgery. All cataract surgery is refractive surgery so it is fair to ask, what is the purpose of including the word “refractive,” as some authors do? What are the credentials that would allow this descriptive term to differentiate it from what all cataract surgeons aspire to? In femtosecond laser–assisted cataract surgery, the clear corneal incision (CCI) can be made with great precision but in refractive terms, that element of the process is carried out by the majority using diamond or steel knives, their aim being to achieve an astigmatically neutral incision or, when the CCI is placed on the steepmeridian and varied inwidth, to reduce preexisting corneal astigmatism. It is too early to confirm whether femtosecond laser–created corneal relaxing incisions prove to be a real advantage in neutralizing preexisting corneal astigmatism. Comparative data with manual relaxing incisions are awaited. The capsulorhexis is, in itself, not a refractive element (although unconfirmed claims are made that femtosecond laser capsulorhexes improve IOL centration with refractive effect) in cataract surgery, nor is nucleus fragmentation, although it can be argued that any aspect of the surgery that reduces phaco power could be contributory. The article by Sorensen et al. in this issue (pages 227-233) provides some evidence on this aspect. Incisional wound contractured “a consequence of ultrasound-induced frictional heat generation resulting in acute collagen contracture once the incisional temperature reaches 60 C”dwill potentially alter corneal shape and therefore its refraction. Sorensen et al. identifymany reasons that incision contracture occurs, the 2 major ones being lack of surgeon expertise and or experience and an untoward effect of some ophthalmic viscosurgical devices on the cooling flow of irrigating fluid. If femtosecond laser nucleus fragmentation reduces phaco power, the