Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens.

PURPOSE: To present the results of a study investigating the 3-year effectiveness and safety of the Clareon single-piece intraocular lens (IOL). SETTING: 19 multinational sites. DESIGN: Prospective multicenter single-arm study. METHODS: Patients were bilaterally implanted with Clareon IOLs. Assessments included uncorrected distance visual acuity, corrected distance visual acuity (CDVA), manifest refraction, tilt, decentration, applanation tonometry, and fundus examination, including glistenings and posterior capsule opacification (PCO) evaluation. The primary outcomes for effectiveness and safety were evaluated at 1 year and compared with ISO historical safety and performance endpoint (SPE) rates. Patients were followed for up to 3 years after implantation. RESULTS: 424 eyes of 215 patients were implanted (n = 215 first eye, n = 209 second eye), and 183 patients completed the trial at 3 years (with 364 binocular and 1 monocular patient). At 1 year, the cumulative and persistent adverse event rates were below SPE targets, and 99.5% of eyes achieved a monocular CDVA of ≤0.3 logMAR (vs the SPE target of 92.5%). At 3 years, the mean monocular CDVA was -0.032, with 93.4% (341/365) of eyes achieving a CDVA of 0.1 logMAR or better, 100% of eyes presented with grade 0 glistenings ≤25 MV/mm 2 , and 92.9% of eyes (394/424) had either no PCO or clinically nonsignificant PCO. CONCLUSIONS: This study supports the long-term safety and effectiveness of the Clareon IOL. The visual outcomes were excellent and stable over the 3-year study period, PCO rates were very low, and 100% of IOLs had grade 0 glistenings.

Visual and Refractive Efficacy of Panoptix Toric Intraocular Lens in a Clinical Setting.

Purpose: Trifocal Intraocular Lenses (IOLs) were developed to provide patients with effective near, intermediate and distance vision, thus minimizing spectacle dependency. Residual astigmatism has previously been shown to impact unaided visual acuity across all distances; therefore, to optimise the expected outcomes, consideration of preoperative corneal astigmatism is essential. The purpose of this study was to provide a real-world, multi-site review of visual and refractive outcomes in eyes undergoing implantation with the Panoptix Trifocal toric IOL platform. Patients and Methods: This study represents a two-fold approach. Patients who had previously undergone routine cataract removal and IOL insertion with the Panoptix Toric IOL were retrospectively analysed for routine efficacy and safety endpoints ("Retrospective Cohort"). Data was retrieved from the preoperative, surgical and postoperative visits (range 2-6 weeks). A further subset of patients undergoing lens removal and bilateral Panoptix Toric IOL insertion were identified at surgery ("Qualitative Cohort"). These patients underwent additional testing inclusive of quality of vision questionnaire and bilateral defocus curve. Results: A total of 466 eyes of 254 patients were included in the retrospective cohort. Between 91% and 98% of eyes, respectively, were within 0.50D and 1.00D of target. Mean absolute difference from Spherical Equivalent (SE) target was 0.22 ± 0.24Ds. Following surgery, 94% of eyes demonstrated a refractive astigmatism of 0.50D or less. Further, 61% eyes achieved uncorrected distance visual acuity (UDVA) of 20/20 or better, increasing to 94% achieving 20/32 or better. Seventy percent of eyes unilaterally achieved N5 unaided and 66.0% achieved N8 or better at intermediate. In the qualitative cohort, no patient described any symptom as significant or requested explant. Conclusion: In a real-world setting, the PanOptix toric trifocal IOL continues to demonstrate refractive accuracy and good visual performance at all focal distances. This IOL also exhibited good quality of vision, with minimally bothersome visual disturbances or photic phenomena.

Multicenter visual outcomes comparison of 2 trifocal presbyopia-correcting IOLs: 6-month postoperative results.

PURPOSE: To clinically evaluate visual performance of the AcrySof IQ PanOptix TFNT00 and AT LISA tri 839MP intraocular lenses (IOLs) in binocular visual acuity (VA) and to characterize low-contrast visual performance at 6 months postimplantation. SETTING: Multicenter, 15 sites. DESIGN: Prospective, parallel-group, randomized, double-masked, postmarketing clinical study. METHODS: Binocular uncorrected distance (UDVA, 4 m), intermediate (UIVA, 60 cm), and near (UNVA, 40 cm) visual acuities and binocular defocus curves were evaluated under photopic lighting conditions. Photopic and mesopic contrast sensitivities with and without glare were assessed. RESULTS: The study included 182 subjects (62% women; mean age, 66 ± 9.4 years) who were implanted bilaterally with the TFNT00 IOL (n = 93) or 839MP IOL (n = 89), and binocular VA was evaluated 4 to 6 months (120-180 days) postimplantation. The TFNT00 IOL group showed superior visual outcomes compared with the 839MP IOL group in binocular UIVA (P = .001) and UNVA (P = .003) and noninferior outcomes in UDVA (95% CI, -0.023 to 0.041; upper limit <0.1 logarithm of the minimum angle of resolution [logMAR] [margin of noninferiority]). Mean defocus curve from 0.00 to -3.00 diopter (D) ranged from 0.1 to 0.0 logMAR for both IOLs; better mean VA values (logMAR) were observed in the TFNT00 IOL group between -1.50 and -2.50 D compared with those of the 839MP IOL group. Contrast sensitivity values were similar between the 2 groups in all conditions. CONCLUSIONS: The results of this study showed improved visual performance at near and intermediate distances with the TFNT00 IOL compared with that of the 839MP IOL.

Visual and refractive outcomes following implantation of a new trifocal intraocular lens.

BACKGROUND: Independence from all optical aids, and freedom from unwanted symptoms, following cataract and lens surgery remains the ultimate goal of both patient and surgeon. The development of trifocal IOL technology provides an ever-increasing range of options. The purpose of our study is to understand the predictability, safety and efficacy of a new trifocal intraocular lens (IOL) following cataract or refractive lens exchange (RLE) surgery. METHODS: This was a retrospective consecutive case series of patients undergoing cataract extraction or RLE followed by implantation of the Alcon IQ Panoptix IOL. Pre and postoperative refractive and visual parameters were recorded and evaluated. As the cohort followed a normal distribution, standard parametric tests were used. Paired t-test was used to compare the difference between target and postoperative refractive errors. The incidence of intraoperative and postoperative complications was also reported. RESULTS: The IOL was implanted in 66 eyes of 33 patients. Mean postoperative spherical equivalent (SE) refraction was -0.08 ± 0.25 dioptres (D). This was not significantly different from the target refraction (p = 0.841). Sixty-five percent of patients were within ± 0.25 D of the target SE refraction with 100% within ± 0.50 D of intended correction. Mean postoperative uncorrected distance visual acuity (UDVA) was 0.01 ± 0.10 LogMAR. All patients achieved an unaided distance acuity of 20/40 or better postoperatively. Binocularly, 100% saw 0.20 LogMAR or better at near without correction and 88.9% achieved this level for uncorrected intermediate visual acuity. No intraoperative complications were noted. Five patients complained of moderate haloes in the early postoperative period. CONCLUSION: The AcrySof IQ Panoptix IOL provides functional uncorrected visual acuity at distance, intermediate and near positions. Our results remain equivalent with existing trifocal IOL outcomes and provide surgeons with a further IOL alternative for the patient motivated to obtain true spectacle independence. Surgeons should consider individual reading and working requirements when counselling patients preoperatively to optimise postoperative patient satisfaction.

Oral antivirals for preventing recurrent herpes simplex keratitis in people with corneal grafts.

BACKGROUND: Ocular herpes is a viral infection of the eye caused by the herpes simplex virus (HSV), a double-stranded DNA virus. Corneal scarring caused by herpes simplex keratitis (HSK) is the leading infectious cause of penetrating corneal graft in high-income countries. Acyclovir is an antiviral drug known to have a protective effect against recurrences in herpetic eye disease. While there are some studies which have evaluated the effects of intervention with oral antiviral in preventing such recurrences in people with corneal grafts, a systematic review of all comparative clinical trials has not been previously undertaken. OBJECTIVES: To assess the efficacy of oral antivirals such as acyclovir in any dosage when taken for six months or more, in preventing recurrence of herpetic keratitis in people having corneal graft surgery for herpetic keratitis. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to June 2016), Embase (January 1980 to June 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 1 June 2016. We handsearched conference proceedings and contacted authors of the included studies and researchers active in the field. SELECTION CRITERIA: We included randomised controlled trials (RCTs). People enrolled in these trials had corneal grafts for HSK. The intervention was oral antivirals for six months or more following the corneal graft surgery, and this was compared to no treatment or placebo. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. We contacted trial investigators for any clarification or missing information. We graded the certainty of the evidence using GRADE. MAIN RESULTS: We included three trials, involving 126 participants, comparing the use of oral acyclovir to no treatment or placebo. Two studies were conducted in single centres in Turkey and the USA, and one was multi-centred in the Netherlands. In general, the studies were poorly reported and it was difficult to judge the extent to which bias had been avoided.Oral acyclovir may reduce the risk of recurrence of herpetic keratitis (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.13 to 0.64, 126 people, low-certainty evidence). Based on data from the included trials, this corresponds to approximately 23 fewer cases of HSK recurrence (95% CI 29 fewer cases to 12 fewer cases) per 100 corneal graft operations if oral acyclovir is used.Oral acyclovir may reduce the risk of graft failure (RR 0.40, 95% CI 0.16 to 0.97, 126 people, low-certainty evidence). Based on data from the included trials, this corresponds to approximately 13 fewer cases of graft failure (95% CI 18 fewer cases to 1 fewer cases) per 100 corneal graft operations if oral acyclovir is used.None of the studies reported any serious side effects of the antivirals necessitating stoppage or change. None of the trials reported outcomes over the long term (more than two years) or any data on quality of life. AUTHORS' CONCLUSIONS: Compared to placebo or to no treatment, oral antiviral (acyclovir) may reduce the risk of recurrence of herpetic keratitis in the first 12 months in eyes that have undergone corneal graft surgery.

Visual outcomes and subjective experience after bilateral implantation of a new diffractive trifocal intraocular lens.

PURPOSE: To assess clinical outcomes and subjective experience after bilateral implantation of a diffractive trifocal intraocular lens (IOL). SETTING: Midland Eye Institute, Solihull, United Kingdom. DESIGN: Cohort study. METHODS: Patients had bilateral implantation of Finevision trifocal IOLs. Uncorrected distance visual acuity, corrected distance visual acuity (CDVA), and manifest refraction were measured 2 months postoperatively. Defocus curves were assessed under photopic and mesopic conditions over a range of +1.50 to -4.00 diopters (D) in 0.50 D steps. Contrast sensitivity function was assessed under photopic conditions. Halometry was used to measure the angular size of monocular and binocular photopic scotomas arising from a glare source. Patient satisfaction with uncorrected near vision was assessed using the Near Activity Visual Questionnaire (NAVQ). RESULTS: The mean monocular CDVA was 0.08 logMAR ± 0.08 (SD) and the mean binocular CDVA, 0.06 ± 0.08 logMAR. Defocus curve testing showed an extended range of clear vision from +1.00 to -2.50 D defocus, with a significant difference in acuity between photopic conditions and mesopic conditions at -1.50 D defocus only. Photopic contrast sensitivity was significantly better binocularly than monocularly at all spatial frequencies. Halometry showed a glare scotoma of a mean size similar to that in previous studies of multifocal and accommodating IOLs; there were no subjective complaints of dysphotopsia. The mean NAVQ Rasch score for satisfaction with near vision was 15.9 ± 10.7 logits. CONCLUSIONS: The trifocal IOL implanted binocularly produced good distance visual acuity and near and intermediate visual function. Patients were very satisfied with their uncorrected near vision.

Design and validity of a miniaturized open-field aberrometer.

PURPOSE: To design and validate a new miniaturized open-field wavefront device that can be attached to an ophthalmic surgical microscope or slitlamp. SETTING: Solihull Hospital and Aston University, Birmingham, United Kingdom. DESIGN: Comparative noninterventional study. METHODS: The dynamic range of the Aston aberrometer was assessed using a calibrated model eye. The validity was compared with that of a conventional desk-mounted Hartmann-Shack aberrometer (Topcon KR1W) in dilated eyes. The instruments were used in random order, with measurements repeated 5 times to assess intrasession repeatability. RESULTS: The open-field aberrometer had a large dynamic range of at least +21.0 diopters (D) to -25.0 D. It gave similar measurements to the conventional aberrometer for mean spherical equivalent (SE) (mean difference 0.02 D ± 0.49 [95% confidence interval]; correlation r = 0.995; P<.001), astigmatic components (J0: 0.02 ± 0.15 D; r = 0.977, P<.001; J45: 0.03 ± 0.28, r = 0.666, P<.001), and higher-order aberration (HOA) root mean square (RMS) (0.02 ± 0.20 D, r = 0.620, P<.001). Intraclass correlation coefficient assessments of intrasession repeatability were excellent (SE = 1.000, P<.001; J0 = 0.998, P<.001; J45 = 0.980, P<.01; HOA RMS = 0.961, P<.001). CONCLUSIONS: The new aberrometer gave valid, repeatable measurements of refractive error and HOAs over a large range. It can measure continuously, thus providing direct feedback on the optical status of the visual system to surgeons during intraocular lens implantation and corneal surgery.

Clinical outcomes after implantation of a new hydrophobic acrylic toric IOL during routine cataract surgery.

PURPOSE: To assess the clinical outcomes after implantation of a new hydrophobic acrylic toric intraocular lens (IOL) to correct preexisting corneal astigmatism in patients having routine cataract surgery. SETTING: Four hospital eye clinics throughout Europe. DESIGN: Cohort study. METHODS: This study included eyes with at least 0.75 diopter (D) of preexisting corneal astigmatism having routine cataract surgery. Phacoemulsification was performed followed by insertion and alignment of a Tecnis toric IOL. Patients were examined 4 to 8 weeks postoperatively; uncorrected distance visual acuity (UDVA), corrected distance visual acuity, manifest refraction, and keratometry were measured. Individual patient satisfaction with uncorrected vision and the surgeon's assessment of ease of handling and performance of the IOL were also documented. The cylinder axis of the toric IOL was determined by dilated slitlamp examination. RESULTS: The study enrolled 67 eyes of 60 patients. Four to 8 weeks postoperatively, the mean UDVA was 0.15 logMAR ± 0.17 (SD) and the UDVA was 20/40 or better in 88% of eyes. The mean refractive cylinder decreased significantly postoperatively, from -1.91 ± 1.07 D to -0.67 ± 0.54 D. No significant change in keratometric cylinder was observed. The mean absolute IOL misalignment from the intended axis was 3.4 degrees (range 0 to 12 degrees). The good UDVA resulted in high levels of patient satisfaction. CONCLUSION: Implantation of the new toric IOL was an effective, safe, and predictable method to manage corneal astigmatism in patients having routine cataract surgery.

A 43-year-old woman on triptorelin presenting with pseudotumor cerebri: a case report.

INTRODUCTION: To the best of our knowledge, this is the first time triptorelin has been reported to cause benign intracranial hypertension. CASE PRESENTATION: A 43-year-old Caucasian woman who suffered from chronic menorrhagia was started on triptorelin, a gonadotrophin-releasing hormone analogue. Three days later, she developed gradually worsening headaches accompanied by bilateral visual disturbance. Examination revealed bilateral papilledema and enlarged blind spots on her visual fields. A diagnosis of benign intracranial hypertension was made and confirmed on magnetic resonance imaging. CONCLUSION: We recommend that patients at high risk (women who are overweight and of reproductive age) who are using any gonadotrophin-releasing hormone analogue (for example, triptorelin) should be periodically monitored for the possible development of benign intracranial hypertension.

Outcomes of deep anterior lamellar keratoplasty following successful and failed 'big bubble'.

AIM: The most popular technique for deep anterior lamellar keratoplasty (DALK) is the 'big bubble' (BB) technique wherein air is injected in the cornea to create a bubble that separates Descemet's membrane (DM) from the stroma. An attempt to create a BB often results in the cornea being filled with numerous small bubbles without the formation of a BB. Manual dissection is then required to complete the procedure. The aim of the study is to compare these two groups, successful BB versus failed bubble (FB) dissection to determine whether the clinical outcomes were different. METHODS: In this retrospective comparative study, 46 patients out of 52 who underwent DALK for various corneal stromal diseases such as keratoconus, stromal dystrophy or corneal scarring (caused by different conditions) were included in the analysis. BB was achieved in 25 patients and in the remaining 21 patients a BB separation of the DM was not possible necessitating manual lamellar dissection of stroma to get as close to the DM as possible. RESULTS: The authors compared best-corrected visual acuity, contrast sensitivity, astigmatism, interface densitometry and Scheimpflug pachymetry in the two groups. Postoperative corneal thickness was higher in the 'small bubbles' group (mean 628.9 vs 564.1 µm; p<0.0005), but there was no significant difference in best-corrected visual acuity, astigmatism, contrast sensitivity and densitometry between the groups. CONCLUSIONS: In DALK, manual lamellar dissection is a reasonable alternative when BB separation of the DM is not achieved.

Bilateral full thickness macular holes in association with serpiginous choroiditis.

PURPOSE: To report serpiginous choroiditis associated with full thickness macular holes (FTMH). DESIGN: Interventional case report. METHODS: A 58-year-old female with bilateral serpiginous choroiditis developed right-sided blurred vision and metamorphopsia. Ocular assessment, FFA, OCT, and right macular hole surgery were performed. RESULTS: Preoperative visual acuity was 6/36 right, 6/9 left. Fundus assessment found bilateral geographic chorioretinal scarring, epiretinal membranes, right FTMH, and mild vitritis. OCT revealed bilateral FTMHs. Pars plana vitrectomy, membrane peel, and gas tamponade resulted in right macular hole closure, visual acuity improvement (6/18) and resolution of metamorphopsia. CONCLUSIONS: Macular hole may be another posterior segment complication of serpiginous choroiditis.

Sequential leukemic infiltration and human herpesvirus optic neuropathy in acute lymphoblastic leukemia.

Leukemic infiltration is a common cause of optic disk swelling in a patient with acute lymphoblastic leukemia (ALL). Recurrence of optic disk swelling in a patient with previous leukemic infiltration carries a grave prognosis when it is associated with recurrent central nervous system disease. We report a case of recurrent swelling of an optic disk in a patient with T-cell ALL who had previously been treated for CNS relapse with optic nerve involvement. In this case the swelling was associated with cytomegalovirus infection and resolved following treatment with antiviral therapy.

Removal of lens epithelial cells and the effect on capsulorhexis size.

PURPOSE: To assess the long-term effects of lens epithelial cell (LEC) removal on capsulorhexis opening size. SETTING: Dorset County Hospital, Dorchester, United Kingdom. METHODS: This prospective randomized control study included 39 eyes of 38 patients. Twenty eyes were selected randomly for removal of LECs from the anterior capsule as part of routine cataract operation comprising phacoemulsification with intraocular lens (IOL) implantation. The other 19 eyes were used as controls in which the LECs were not removed. All surgeries were performed by 1 surgeon (A.T.). All patients had silicone IOL (Allergan SI-40) implantation. The capsulorhexis opening size was determined immediately after surgery and 2 weeks and 6 months after surgery. Data on treatment outcome of the cataract surgery were analyzed statistically. RESULTS: Six months postoperatively, the size of the capsulorhexis had statistically significant increased in the study group that had LECs removed (mean increase 1.07 +/- 1.70 mm(2); paired Student t test P=.01), whereas the capsulorhexis size had statistically significant decreased in the control group (mean decrease -3.38 +/- 2.37 mm(2); paired Student t test, P<.0001). The difference in changes in the capsulorhexis areas between the 2 groups was also highly statistically significant (independent-sample Student t test, P<.0001). CONCLUSION: Removal of anterior subcapsular LECs by aspiration helped maintain the size of the capsulorhexis opening and thus can help prevent capsule contraction syndrome.