Classification of Presbyopia by Severity.

There are close to two billion individuals globally living with presbyopia. In spite of its ubiquitous and progressive nature, there is no widely accepted, formal guideline or consensus statement on the classification of presbyopia by degree of severity. A panel of leading eye care professionals representing both optometrists and ophthalmologists convened virtually to discuss and document their combined assessments from the body of literature and clinical practice expertise in this commentary. In light of emerging therapies, classifying presbyopia by mild, moderate, or advanced severity may help provide consistency of diagnosis among eye care providers and may aid in managing patient expectations with different treatment options.

Corneal crosslinking without epithelial removal.

PURPOSE: To evaluate the effect of riboflavin-ultraviolet (UV)-A corneal crosslinking (CXL) without epithelial removal on ectatic corneal disease. SETTING: Woolfson Eye Institute, Atlanta, Georgia, USA. DESIGN: Prospective observational study. METHODS: Patients were treated with a new riboflavin formulation without epithelial removal, then exposed to UV light (365 nm) at 4 mW/cm2 with on-off cycling for 30 minutes. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, maximum corneal curvature (maximum keratometry [Kmax]), total higher-order aberrations (HOAs), and coma were measured at 3, 6, 12, and 24 months postoperatively. Progression was defined as an increase of more than 1 diopter (D) in Kmax and loss of more than 1 line of CDVA. RESULTS: Five hundred twelve eyes of 308 patients with keratoconus or forme fruste keratoconus and 80 eyes of 55 patients with ectasia after laser in situ keratomileusis (LASIK) were treated with the new riboflavin formulation without epithelial removal; 229 patients received bilateral treatments, 95 of which were simultaneous. The mean UDVA and CDVA improved by 1 to 1.5 Snellen lines at 1 and 2 years postoperatively (P < .0001). Mean Kmax decreased by 0.48 D at 2 years postoperatively (P = .0002). Mean total HOAs and coma decreased by 36% (P < .0001) and 37% (P = .0002), respectively, at 2 years postoperatively. Kmax decreased more than 1 D in three times as many eyes as it increased more than 1 D (P < .0001). No eyes progressed, and there was no loss of effect between 1 and 2 years postoperatively. No vision-threatening events were observed. Pain typically resolved within 24 hours, and visual acuity returned to preoperative levels in 1 to 2 days. CONCLUSION: Epithelium-on CXL using this new protocol halted the progression of keratoconus and ectasia after LASIK. It was safer and provided more rapid visual recovery than CXL with epithelial removal, allowing routine bilateral, simultaneous treatment.

The Prospective Health Assessment of Cataract Patients' Ocular Surface (PHACO) study: the effect of dry eye.

PURPOSE: To determine the incidence and severity of dry eye as determined by the International Task Force (ITF) scale in patients being screened for cataract surgery. PATIENTS AND METHODS: This was a prospective, multi-center, observational study of 136 patients, at least 55 years of age, who were scheduled to undergo cataract surgery. The primary outcome measure was the incidence of dry eye as evaluated by grade on the ITF scale and secondary outcome measures include tear break-up time (TBUT), ocular surface disease index score, corneal staining with fluorescein, conjunctival staining with lissamine green, and a patient questionnaire to evaluate symptoms of dry eye. RESULTS: Mean patient age was 70.7 years. A total of 73.5% of patients were Caucasian and 50% were female. Almost 60% had never complained of a foreign body sensation; only 13% complained of a foreign body sensation half or most of the time. The majority of patients (62.9%) had a TBUT ≤5 seconds, 77% of eyes had positive corneal staining and 50% of the eyes had positive central corneal staining. Eighteen percent had Schirmer's score with anesthesia ≤5 mm. CONCLUSION: The incidence of dry eye in patients scheduled to undergo cataract surgery in a real-world setting is higher than anticipated.

Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies.

PURPOSE: To evaluate the efficacy and safety of phenylephrine 1.0%-ketorolac 0.3% (Omidria) for maintenance of mydriasis during, and reduction of ocular pain after, cataract surgery. SETTING: Twenty centers in the United States and the Netherlands. DESIGN: Prospective randomized clinical trials. METHODS: Patients having cataract surgery or refractive lens exchange were enrolled in 2 clinical trials. Phenylephrine 1.0%-ketorolac 0.3% or placebo was added to irrigation solution and administered intracamerally during the procedure. Integrated analyses of primary and secondary endpoints were conducted. RESULTS: The clinical trials comprised 808 patients (403 treatment and 405 placebo). Phenylephrine 1.0%-ketorolac 0.3% was superior to placebo for the maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. The mean area under the curve (AUC) change from baseline in pupil diameter was 0.08 mm for treatment compared with -0.50 mm for placebo (P < .0001). The mean AUC of ocular pain visual analog scale scores within 12 hours postoperatively was 4.16 mm for the treatment group and 9.06 mm for the placebo group (P < .001). Results of all secondary efficacy analyses demonstrated a significant treatment effect associated with phenylephrine 1.0%-ketorolac 0.3%. Treatment-emergent adverse events were as expected for a population having cataract surgery; no clinically significant differences in safety measures were observed between treatment groups. CONCLUSION: In this integrated analysis, phenylephrine 1.0%-ketorolac 0.3% administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis during the procedure and reducing postoperative ocular pain. FINANCIAL DISCLOSURE: Dr. Schaaf is an employee and holds an equity interest in Omeros Corporation. Drs. Hovanesian, Sheppard, Trattler, Gayton, and Ng are consultants to Omeros Corporation. No other author has a financial or proprietary interest in any material or method mentioned.

Sources of medical error in refractive surgery.

PURPOSE: To evaluate the causes of laser programming errors in refractive surgery and outcomes in these cases. METHODS: In this multicenter, retrospective chart review, 22 eyes of 18 patients who had incorrect data entered into the refractive laser computer system at the time of treatment were evaluated. Cases were analyzed to uncover the etiology of these errors, patient follow-up treatments, and final outcomes. The results were used to identify potential methods to avoid similar errors in the future. RESULTS: Every patient experienced compromised uncorrected visual acuity requiring additional intervention, and 7 of 22 eyes (32%) lost corrected distance visual acuity (CDVA) of at least one line. Sixteen patients were suitable candidates for additional surgical correction to address these residual visual symptoms and six were not. Thirteen of 22 eyes (59%) received surgical follow-up treatment; nine eyes were treated with contact lenses. After follow-up treatment, six patients (27%) still had a loss of one line or more of CDVA. Three significant sources of error were identified: errors of cylinder conversion, data entry, and patient identification error. CONCLUSION: Twenty-seven percent of eyes with laser programming errors ultimately lost one or more lines of CDVA. Patients who underwent surgical revision had better outcomes than those who did not. Many of the mistakes identified were likely avoidable had preventive measures been taken, such as strict adherence to patient verification protocol or rigorous rechecking of treatment parameters.

Femtosecond lasers for LASIK flap creation: a report by the American Academy of Ophthalmology.

OBJECTIVE: To review the published literature to assess the safety, efficacy, and predictability of femtosecond lasers for the creation of corneal flaps for LASIK; to assess the reported outcomes of LASIK when femtosecond lasers are used to create corneal flaps; and to compare the differences in outcomes between femtosecond lasers and mechanical microkeratomes. METHODS: Literature searches of the PubMed and Cochrane Library databases were last conducted on October 12, 2011, without language or date limitations. The searches retrieved a total of 636 references. Of these, panel members selected 58 articles that they considered to be of high or medium clinical relevance, and the panel methodologist rated each article according to the strength of evidence. Four studies were rated as level I evidence, 14 studies were rated as level II evidence, and the remaining studies were rated as level III evidence. RESULTS: The majority of published studies evaluated a single laser platform. Flap reproducibility varied by device and the generation of the device. Standard deviations in flap thicknesses ranged from 4 to 18.4 µm. Visual acuities and complications reported with LASIK flaps created using femtosecond lasers are within Food and Drug Administration safety and efficacy limits. Of all complications, diffuse lamellar keratitis is the most common after surgery but is generally mild and self-limited. Corneal sensation was reported to normalize by 1 year after surgery. Unique complications of femtosecond lasers included transient light-sensitivity syndrome, rainbow glare, opaque bubble layer, epithelial breakthrough of gas bubbles, and gas bubbles within the anterior chamber. CONCLUSIONS: Available evidence (levels I and II) indicates that femtosecond lasers are efficacious devices for creating LASIK flaps, with accompanying good visual results. Overall, femtosecond lasers were found to be as good as or better than mechanical microkeratomes for creating LASIK flaps. There are unique complications that can occur with femtosecond lasers, and long-term follow-up is needed to evaluate the technology fully.

Comparison of prediction error: labeled versus unlabeled intraocular lens manufacturing tolerance.

PURPOSE: To compare the prediction error between intraocular lenses (IOLs) available in 0.25 diopter (D) increments with a labeled manufacturing tolerance and IOLs available in 0.50 D increments without a labeled manufacturing tolerance. SETTING: Community-based multidisciplinary outpatient ophthalmic practices. DESIGN: Comparative case series. METHODS: Eyes with cataract had implantation of an IOL available in 0.25 D increments and labeled with a manufacturing tolerance of ± 0.11 D (labeled group) or an IOL available in 0.50 D increments without a labeled manufacturing tolerance (unlabeled group). Postoperatively, the prediction error was calculated and compared between groups. RESULTS: By the SRK/T formula, the mean error of prediction after optimization was -0.03 D ± 0.35 (SD) in the labeled group and -0.05 ± 0.46 D in the unlabeled group (P=.64). The mean absolute error of prediction was statistically significantly smaller in the labeled group (0.26 ± 0.23 D) than in the unlabeled group (0.37 ± 0.28 D) (P=.04). The mean and absolute errors were not statistically significantly different with the Holladay 1 or Hoffer Q formula. Sixty-three percent of patients in the labeled group and 43% in the unlabeled group (P=.03) were within ± 0.25 D of the prediction error; 84% and 69%, respectively, were within ± 0.50 D (P=.06). CONCLUSION: The IOLs available in 0.25 D increments with a labeled manufacturing tolerance of ± 0.11 D increased the percentage of patients within ± 0.25 D of the targeted refraction to a statistically significant and clinically meaningful level compared with unlabeled IOLs available in 0.50 D increments. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Prospective multicenter trial assessing effectiveness, refractive predictability and safety of a new aberration free, bi-aspheric intraocular lens.

PURPOSE: To determine the effectiveness and safety of the Softec HD IOL; and to present refractive outcomes for lenses manufactured at an IOL power tolerance of 0.11 D. METHODS: Three-hundred and ninety adult patients requiring removal of a cataractous lens with implantation of a monofocal IOL in at least one eye were eligible for study participation across eight US investigative sites. Patients were enrolled unilaterally. After routine surgery, subjects were examined for adverse events (AEs), best corrected visual acuity (BCVA) and manifest refraction correction at 12 months postoperatively. RESULTS: Three-hundred and sixty-six (95%) of patients completed the 12-month postoperative visit. The percent of patients achieving best corrected Snellen acuity 20/40 or better was 98.9%, and 81.1% of patients achieved best corrected Snellen acuity 20/25 or better. Of those patients (80%) implanted with a lens available in 0.25 D increments (manufactured at a tolerance of 0.11 D) 40.9%, 69.8% and 93.8% of patients were within ±0.25 D, ±0.50 D and ±1.0 D of predicted target refraction respectively. Overall incidence of cumulative and persistent IOL Grid AEs was 2.2% with no AE meeting or exceeding the FDA Grid of Historical Controls. CONCLUSIONS: The Softec HD IOL is a safe and effective lens. The high manufacturing tolerance of the lens appears to enhance refractive outcomes.

Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension.

PURPOSE: To compare the ocular surface tolerability of latanoprost 0.005% preserved with 0.02% benzalkonium chloride (BAK), bimatoprost 0.03% preserved with 0.005% BAK, and travoprost 0.004% preserved with the proprietary preservative system sofZia in patients previously treated with latanoprost. METHODS: This randomized, multicenter, investigator-masked, parallel-group study enrolled patients with open-angle glaucoma or ocular hypertension who had been on latanoprost monotherapy for at least 4 weeks. At baseline, patients were randomized to receive once-daily bimatoprost (n=35), latanoprost (n=38), or travoprost (n=33) monotherapy for 3 months. Follow-up visits were at week 1, month 1, and month 3. The primary outcome measure was physician-graded conjunctival hyperemia at month 3. Secondary outcome measures included corneal staining with fluorescein and tear breakup time (TBUT). RESULTS: There were no significant differences among the treatment groups in conjunctival hyperemia scores, corneal staining, or TBUT at the latanoprost-treated baseline or at any follow-up visit. Baseline mean (standard error of the mean) values were as follows--conjunctival hyperemia: bimatoprost 0.74 (0.10), latanoprost 0.74 (0.11), travoprost 0.86 (0.12), P=0.692; corneal staining: bimatoprost 0.59 (0.12), latanoprost 0.70 (0.13), travoprost 0.48 (0.11), P=0.423; TBUT (in seconds): bimatoprost 9.1 (1.0), latanoprost 8.6 (0.8), travoprost 7.9 (0.8), P=0.578. Month 3 values were as follows--conjunctival hyperemia: bimatoprost 0.80 (0.12), latanoprost 0.74 (0.10), travoprost 0.98 (0.13), P=0.340; corneal staining: bimatoprost 0.71 (0.78), latanoprost 0.47 (0.64), travoprost 0.36 (0.62), P=0.110; TBUT (in seconds): bimatoprost 9.7 (5.3), latanoprost 9.2 (5.3), travoprost 9.7 (6.3), P=0.909. CONCLUSIONS: There were no significant differences among bimatoprost (preserved with 0.005% BAK), latanoprost (preserved with 0.02% BAK), and travoprost (preserved with sofZia) in objective clinical measures of ocular tolerability, including physician-graded hyperemia, corneal staining, and TBUT after 3 months of treatment. Longer-term studies are needed to further evaluate the ocular surface tolerability of these prostaglandin analogs.

Evaluation of a risk factor scoring system for corneal ectasia after LASIK in eyes with normal topography.

PURPOSE: To assess a previously published risk score system for predicting postoperative LASIK ectasia in eyes with normal preoperative topography. METHODS: A retrospective review of one surgeon's LASIK database was performed for eyes with Randleman ectasia risk scores based on patient age <30 years, preoperative central corneal thickness <510 microm, residual stromal bed thickness <300 microm, and/or a preoperative manifest refraction spherical equivalent >-8.00 diopters that had a minimum follow-up of 1 year. RESULTS Of 1702 eyes with myopic errors and normal topographies, 35 (2.0%) eyes had a combined risk score between 5 and 9 points, 92 (5.4%) eyes had a combined risk score of 4 or higher, and 208 (12.2%) eyes had a combined score of 3 or higher. None of these eyes developed ectasia, whereas 3 eyes with preoperative topographic keratoconus with no other risk factors developed ectasia. CONCLUSIONS: The current risk score system would have eliminated 5.4% of eyes with 4 or more points from LASIK surgery, and would have also required the surgeon to advise an additional 6.8% of eyes with a score of 3 that they were at "moderate risk" and should "proceed with caution." In eyes with normal preoperative topographies, the scoring system may not accurately predict whether patients are at increased risk for developing postoperative LASIK ectasia.

Phakic intraocular lens implantation for the correction of myopia: a report by the American Academy of Ophthalmology.

OBJECTIVE: To review the published literature for evaluation of the safety and outcomes of phakic intraocular lens (pIOL) implantation for the correction of myopia and myopic astigmatism. METHODS: Literature searches of the PubMed and Cochrane Library databases were conducted on October 7, 2007, and July 14, 2008. The PubMed search was limited to the English language; the Cochrane Library was searched without language limitations. The searches retrieved 261 references. Of these, panel members chose 85 papers that they considered to be of high or medium clinical relevance to this assessment. The panel methodologist rated the articles according to the strength of evidence. RESULTS: Two pIOLs have been approved by the US Food and Drug Administration (FDA): one iris-fixated pIOL and one posterior-chamber IOL. In FDA trials of iris-fixated pIOLs, uncorrected visual acuity (UCVA) was >or=20/40 in 84% and >or=20/20 in 31% after 3 years. In FDA trials of posterior-chamber pIOLs, UCVA was >or=20/40 in 81% and >or=20/20 in 41%. Satisfaction with the quality of vision with both types of pIOLs was generally high. Toric anterior- and posterior-chamber pIOLs have shown improved clinical results in European trials compared with spherical pIOLs. Comparative studies showed pIOLs to provide better best spectacle-corrected visual acuity (BSCVA) and refractive predictability and stability compared with LASIK and photorefractive keratectomy and to have a lower risk of retinal detachment compared with refractive lens exchange. Reported complications and long-term safety concerns include endothelial cell loss, cataract formation, secondary glaucoma (pupillary block, pigment dispersion), iris atrophy (pupil ovalization), and traumatic dislocation. CONCLUSIONS: Phakic IOL implantation is effective in the correction of myopia and myopic astigmatism. In cases of high myopia of -8 diopters or more, pIOLs may provide a better visual outcome than keratorefractive surgeries and better safety than refractive lens exchange. The short-term rates of complications and loss of BSCVA are acceptable. Comprehensive preoperative evaluation and long-term postoperative follow-up examinations are needed to monitor for and prevent serious complications, and to establish long-term safety.

Topical bromfenac 0.09% vs. ketorolac 0.4% for the control of pain, photophobia, and discomfort following PRK.

PURPOSE: To compare the efficacy of two topical nonsteroidal anti-inflammatory drugs with regards to the control of pain, burning, photophobia, foreign body sensation, and epithelial healing rates in patients who underwent photorefractive keratectomy (PRK). METHODS: Two hundred twelve eyes were randomized to receive topical postoperative ketorolac 0.4% four times daily (Acular LS, Allergan) or bromfenac 0.09% twice daily (Xibrom, ISTA Pharmaceuticals) in an open label trial. Patients having both eyes treated received ketorolac in one eye and bromfenac in the other. The epithelium was removed using the 8.4-mm Amoils brush (Innovative Excimer Solutions), and various laser beam platforms were permitted for the surgery. Investigated drugs were applied after a bandage contact lens (Acuvue Oasys, Johnson & Johnson Vision Care) was fitted. All patients received postoperative cold saline (balanced saline solution [BSS]), prednisolone acetate 1.0% (Pred Forte, Allergan), gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan), and in some cases, mitomycin C 0.02% (MMC). Patients recorded postoperative results for pain, photophobia, burning, and foreign-body sensation on a visual linear analog scale. During postoperative follow-up, the corneal epithelial defect was measured. RESULTS: Two hundred twelve eyes from 149 patients were enrolled in the study. Of these eyes, 105 received bromfenac and 107 received ketorolac. No significant differences were noted in postoperative pain, burning, foreign-body sensation, and photophobia between the two drug populations at any time during the study or overall. There were no drug-related adverse events or differences in epithelial healing rates for either drug. CONCLUSIONS: No significant differences were observed between the use of bromfenac (twice daily) and ketorolac (four times daily) with regard to postoperative PRK discomfort and safety when combined with postoperative measures such as cold BSS and a bandage contact lens.

Presbyopia-correcting intraocular lenses.

PURPOSE OF REVIEW: Multifocal and accommodating intraocular lenses (IOLs) were introduced 2 decades ago and have gone through several iterations. This technology has allowed ophthalmologists to provide their cataract surgery patients with a broader range of visual function. The purpose of this article is to discuss the currently available presbyopia-correcting IOLs, the role of patient selection, and future technologies. RECENT FINDINGS: Newer versions of both the multifocal and accommodating IOLs offer better vision at distance, intermediate, and near than their predecessors. The procedure remains attractive for patients with cataracts or those who are too hyperopic for corneal surgery. However, following successful implantation of the latest generation of lenses, some patients are still not completely satisfied with their visual results. Additional procedures, such as yttrium aluminum garnet (YAG) capsulotomies or reduction of astigmatism and refractive error or both, may be required to increase patient satisfaction. SUMMARY: Experience has shown us that the majority of patients who present with cataracts are potential candidates for multifocal or accommodating IOLs. Familiarity with accommodative and multifocal lenses, in conjunction with careful patient selection, maximizes surgical success in this challenging group of surgical patients.

Wavefront-guided LASIK for the correction of primary myopia and astigmatism a report by the American Academy of Ophthalmology.

OBJECTIVE: To describe wavefront-guided (WFG) LASIK for the primary treatment of low to moderate levels of myopia and astigmatism and to examine the evidence on the safety and effectiveness of the procedure in comparison with conventional LASIK. METHODS: Literature searches conducted in 2004, 2005, 2006, and 2007 retrieved 209 unique references from the PubMed and Cochrane Library databases. The panel selected 65 articles to review, and of these, chose 45 articles that they considered to be of sufficient clinical relevance to submit to the panel methodologist for review. During the review and preparation of this assessment, an additional 2 articles were included. A level I rating was assigned to properly conducted, well-designed, randomized clinical trials; a level II rating was assigned to well-designed cohort and case-controlled studies; and a level III rating was assigned to case series, case reports, and poorly designed prospective and retrospective studies. In addition, studies that were conducted by laser manufacturers before device approval (premarket approval) were reviewed as a separate category of evidence. RESULTS: The assessment describes studies reporting results of WFG LASIK clinical trials, comparative trials, or both of WFG and conventional LASIK that were rated level II and level III. There were no studies rated as level I evidence. Four premarket approval studies conducted by 4 laser manufacturers were included in the assessment. The assessment did not compare study results or laser platforms because there were many variables, including the amount of follow-up, the use of different microkeratomes, and the level of preoperative myopia and astigmatism. CONCLUSIONS: There is substantial level II and level III evidence that WFG LASIK is safe and effective for the correction of primary myopia or primary myopia and astigmatism and that there is a high level of patient satisfaction. Microkeratome and flap-related complications are not common but can occur with WFG LASIK, just as with conventional LASIK. The WFG procedure seems to have similar or better refractive accuracy and uncorrected visual acuity outcomes compared with conventional LASIK. Likewise, there is evidence of improved contrast sensitivity and fewer visual symptoms, such as glare and halos at night, compared with conventional LASIK. Even though the procedure is designed to measure and treat both lower- and higher-order aberrations (HOAs), the latter are generally increased after WFG LASIK. The reasons for the increase in HOA are likely multifactorial, but the increase typically is less than that induced by conventional LASIK. No long-term assessment of WFG LASIK was possible because of the relatively short follow-up (12 months or fewer) of most of the studies reviewed.