Salvatore Cillino

Deep sclerectomy versus punch trabeculectomy with or without phacoemulsification: a randomized clinical trial.

Purpose:To compare the efficacy of non-penetrating deep sclerectomy without implant with Crozafon-De Laage punch trabeculectomy, and to evaluate the effect of simultaneous temporal approach phacoemulsification on both techniques. Patients and Methods:Setting: Department of Ophthalmology of the University of Palermo. Design:Prospective randomized clinical trial. Patients and intervention procedures: Sixty-five patients (65 eyes) with primary open angle glaucoma (POAG) or pseudoexfoliative glaucoma (PEXG): 32 eyes underwent non-penetrating deep sclerectomy (NPDS), 17 as single procedure and 15 combined with phacoemulsification (phaco-NPDS), and 33 eyes underwent punch trabeculectomy (PT), 18 single and 15 with phaco (phaco-PT). The patients were randomly assigned to each procedure. No adjuvants, such as Nd: YAG laser goniopuncture, laser suturelysis, and antimetabolites were used. Main Outcome Measures: Postoperative complications, number of antiglaucoma medications, and IOP level were checked at each control. Complete success indicated the achievement of the target IOP without antiglaucoma medications, while qualified success indicated the same goal with or without medications. These categories were assessed at two target IOP levels, namely ≤21 mm Hg and ≤17 mm Hg in all four groups. Results:The mean follow-up period was 22.5 ± 2.5 months. The mean preoperative IOP was 30.2 mm Hg in NPDS eyes, 26.8 in phaco-NPDS eyes, 32.1 in PT eyes, and 27.0 in phaco-PT ones, without significant intergroup difference. At the end point the mean IOP was 17.7 ± 0.8, 15.7 ± 0.9, 14.2 ± 1.1, and 13.8 ± 1.1 mm Hg respectively with postoperative IOP significantly lower (P = 0.005) than preoperative IOP in all groups. No difference was observed among groups at any observation time when simple and combined surgery were compared. Significant difference at the end point was found between NPDS and PT (P = 0.030). As for complete and qualified success with a ≤21 and ≤17 mm Hg target IOP no significant differences were noticed in all groups. Among postoperative complications, hypotony was significantly more frequent in both PT groups when compared with the NPDS groups. The same was true, but relating only to the single procedures, for shallow anterior chamber and choroidal detachment. The Kaplan-Meier cumulative survival curves relating to the qualified success rate in the four surgical groups for a ≤21 mm Hg target IOP (log rank, P = 0.564) and for a ≤17 mm Hg target IOP (log rank, P = 0.591) showed no significant intergroup differences. When the ≤21 mm Hg target IOP was considered, a mild positive trend in combined procedures (both phaco-NPDS and phaco-PT) was found in comparison with simple procedures. At lower IOP target (ie, ≤17 mm Hg) a better trend was found in favor of simple or combined PT procedure. Conclusions:Both techniques, NPDS and PT, without enhancements (ie, implants or antimetabolites) control IOP efficaciously at our end point. Phacoemulsification combined with penetrating and non-penetrating procedures does not seem to interfere with final results. When a lower target IOP and probability of success over time are considered, PT, single or combined, exhibits a better trend. PT, therefore, could be more suitable for higher IOP levels or longer life expectancies.

A five-year retrospective study of the epidemiological characteristics and visual outcomes of patients hospitalized for ocular trauma in a Mediterranean area

BackgroundTo determine the epidemiological characteristics and visual outcome of ocular trauma in southern Italy.MethodsAll cases of ocular trauma admitted to Department of Ophthalmology of Palermo University, Italy, from January 2001–December 2005 were retrospectively reviewed for open- or closed-globe injury (OGI or CGI). Data extracted included age, sex, residence, initial and final visual acuity (VA), cause and treatment of injury, hospitalization. The injuries were classified by Ocular Trauma Classification System (OTCS) and Birmingham Eye Trauma Terminology (BETT). We also referred to the Ocular Trauma Score (OTS) in evaluating the final visual outcome.ResultsOf the 298 eyes, there were 146 OGI and 152 CGI. Fifty eyes (16.8%) had an intraocular foreign body (IOFB). The annual incidence of eye injuries was 4.9 per 100,000. Most injuries occurred in men (84.6%, p < 0.0005), with an average age of 33.0 vs. 49.9 for women (p = 0.005). Cause of injury differed significantly by gender (p = 0.001) and urban vs. rural location (p = 0.009). The most frequent causes in men were outdoor activities related injuries (30.9%), work-related (25.4%), and sport-related (17.5%), and in women were home-related (52.2%) and outdoor activities related injuries (30.4%). In urban areas, road accidents were more frequent; in rural areas, work-related injuries were more frequent with a greater rate of IOFBs than in urban areas (p = 0.002).The incidence of OGI and CGI differed in work-related injuries (p < 0.0005), sport-related injuries (p < 0.0005), and assaults (p = 0.033). The final visual acuity was 20/40 (6/12) or better in 144 eyes (48.3%), 20/40–20/200 (6/12–6/60) in 90 eyes (30.2%), and <20/200 (6/60) or less in 46 eyes (15.5%). Eighteen eyes (6%) had a final acuity of no light perception. Of those eyes that presented with hand motion vision or better, 220 (86.6%) had a final vision of better than 20/200 (6/60). Initial visual acuity was found to be correlated with final visual acuity (Spearmans correlation coefficient = 0.658; p < 0.001). The likelihood of the final visual acuities in the OTS categories was correlated to that of the OTS study group in 12 of 14 cases (85.7%).ConclusionThis analysis provides insight into the epidemiology of patients hospitalized for ocular trauma. The findings indicate that ocular trauma is a significant cause of visual loss in this population.

Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial.

AimTo verify the safety and efficacy of Ologen (OLO) implant as adjuvant compared with low-dosage mitomycin-C (MMC) in trabeculectomy.MethodsThis was a prospective randomized clinical trial with a 24-month follow-up. Forty glaucoma patients (40 eyes) were assigned to trabeculectomy with MMC or OLO. Primary outcome includes target IOP at ≤21, ≤17, and ≤15 mm Hg; complete (target IOP without medications), and qualified success (target IOP regardless of medications). Secondary outcomes include bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain optical coherence tomography (SD-OCT) examination; number of glaucoma medications; and frequency of postoperative adjunctive procedures and complications.ResultsThe mean preoperative IOP was 26.5 (±5.2) in MMC and 27.3 (±6.0) in OLO eyes, without statistical significance. One-day postoperatively, the IOP dropped to 5.2 (±3.5) and 9.2 (±5.5) mm Hg, respectively (P=0.009). The IOP reduction was significant at end point in all groups (P=0.01), with a mean IOP of 16.0 (±2.9) and 16.5 (±2.1) mm Hg in MMC and OLO, respectively. The rates and Kaplan–Meier curves did not differ for both complete and qualified success at any target IOP. The bleb height in OLO group was higher than MMC one (P<0.05). SD-OCT analysis of successful/unsuccessful bleb in patients with or without complete success at IOP ≤17 mm Hg indicated a sensitivity of 83% and 73% and a specificity of 75% and 67%, respectively, for MMC and OLO groups. No adverse reaction to OLO was noted.ConclusionsOur results suggest that OLO implant could be a new, safe, and effective alternative to MMC, with similar long-term success rate.

Is ranibizumab effective in stopping the loss of vision for choroidal neovascularisation in pathologic myopia? A long-term follow-up study

Aim To assess the efficacy and safety of ranibizumab in the treatment of choroidal neovascularisation (CNV) caused by pathologic myopia (PM). Design Prospective, multicentre, interventional case series. Methods 40 eyes of 39 consecutive patients with PM and CNV were treated with ‘on demand’ intravitreal injection of ranibizumab 0.5 mg. Final best corrected visual acuity (BCVA) and its change from baseline were the main outcome measures. Changes in optical coherence tomography (OCT) central retinal thickness (CRT) were a secondary outcome. Results Mean age was 53±13 years and mean refractive error –13.5±6.5 D. Median follow-up was 13.3±2 (range 12–18) months. Fifteen eyes (37.5%) had previously been treated with photodynamic therapy (PDT). The mean baseline logarithm of the minimum angle of resolution (logMAR) BCVA (Early Treatment Diabetic Retinopathy Study (ETDRS) vision chart) was 0.68±0.34 (Snellen equivalent 20/131) and 21±16 letters. The final mean logMAR BCVA was 0.27±0.2 (p = 0.008) (20/42) and 40.5±14 letters (p = 0.01). Mean final VA improved in 82.5% of patients, in 60% by 3 or more lines (median number of lines gained 2.9). Even six out of seven cases of low vision (≤1.1 logMAR) at the final examination has improved vision. Mean OCT CRT reduced from 218±70 to 175±46 μm (p 0.02). Age and previous PDT did not influence the results (p>0.05). The mean number of injection was 2.8±1.2 (range 1–6). No ocular or systemic side effects were observed. Conclusion Ranibizumab was an effective treatment for stabilising and improving vision with a low number of injections in 92.5% of patients with myopic CNV in a long-term follow-up.

Deep sclerectomy versus trabeculectomy with low-dosage mitomycin C: four-year follow-up.

Aims: To compare the long-term effects of low-dosage mitomycin C (MMC) in both deep sclerectomy (DSMMC) and trabeculectomy (TPMMC) on intraocular pressure (IOP). Methods: Analysis of extended follow-up of data from a prospective clinical trial. Forty patients were originally randomised to undergo either DSMMC (19 eyes) or TPMMC (21 eyes). Follow-up was performed at postoperative day 1, weeks 1, 2 and 3, as well as months 1, 3, 6, 9, 12, 18, 24, 36 and 48. Two- to three-week data were not included in the statistical analysis. Postoperative complications, number of antiglaucoma medications and IOP were recorded at each visit. Complete (no medications) and qualified (with or without medications) successes were assessed at 2 target IOPs (≤21 and ≤17 mm Hg) and evaluated by Kaplan-Meier curves. Results: At 48 months, the mean IOP (± SD) was 17.6 ± 3.4 and 17.8 ± 3.6 mm Hg in the DSMMC and TPMMC eyes, respectively, a significant reduction from preoperative IOP in each group (p < 0.0005). Complete success was achieved at the ≤21 mm Hg target IOP in 10 (52.6%) and 14 (66.6%) eyes and qualified success in 15 (78.9%) and 18 (85.7%) eyes in the DSMMC and TPMMC groups, respectively. There were no differences in the Kaplan-Meier curves. Hypotony and shallow anterior chamber were significantly more frequent in the TPMMC group. Conclusions: Either procedure controlled IOP efficaciously at our endpoint. Low-dosage MMC can be considered a mild enhancement of deep sclerectomy IOP-lowering effect.

Long-term efficacy of botulinum toxin A for treatment of blepharospasm, hemifacial spasm, and spastic entropion: a multicentre study using two drug-dose escalation indexes

PurposeTo investigate the long-term effectiveness and safety of botulinum neurotoxin A (BoNT-A) treatment in patients with blepharospasm (BEB), hemifacial spasm (HFS), and entropion (EN) and to use for the first time two modified indexes, ‘botulin toxin escalation index-U’ (BEI-U) and ‘botulin toxin escalation index percentage’ (BEI-%), in the dose-escalation evaluation.MethodsAll patients in this multicentre study were followed for at least 10 years and main outcomes were clinical efficacy, duration of relief, BEI-U and BEI-%, and frequency of adverse events.ResultsBEB, HFS, and EN patients received a mean BoNT-A dose with a significant inter-group difference (P<0.0005, respectively). The mean (±SD) effect duration was statistically different (P=0.009) among three patient groups. Regarding the BoNT-A escalation indexes, the mean (±SD) values of BEI-U and BEI-% were statistically different (P=0.035 and 0.047, respectively) among the three groups. In BEB patients, the BEI-% was significantly increased in younger compared with older patients (P=0.008). The most frequent adverse events were upper lid ptosis, diplopia, ecchymosis, and localized bruising.ConclusionsThis long-term multicentre study supports a high efficacy and good safety profile of BoNT-A for treatment of BEB, HFS, and EN. The BEI indexes indicate a significantly greater BoNT-A-dose escalation for BEB patients compared with HFS or EN patients and a significantly greater BEI-% in younger vsolder BEB patients. These results confirm a greater efficacy in the elderly and provide a framework for long-term studies with a more flexible and reliable evaluation of drug-dose escalation.

Deep Sclerectomy versus Punch Trabeculectomy: Effect of Low-Dosage Mitomycin C

Purpose: To compare IOP behavior after deep sclerectomy (DS) and trabeculectomy with the Crozafon-De Laage Punch (TP), using low-dosage intraoperative mitomycin C (MMC) in both techniques. Methods: The study was a prospective randomized clinical trial. All patients met inclusion and exclusion criteria, and were scheduled for glaucoma surgery. Forty patients were randomized to undergo either a nonpenetrating DS with MMC (DSMMC) (19 eyes) or a TP with MMC (TPMMC) (21 eyes). Postoperative examinations were performed at the 1st day, the 1st, 2nd and 3rd weeks and the 1st, 3rd, 6th, 9th and 12th months. Postoperative complications, number of antiglaucoma medications and the IOP level were checked at each control. Complete success (without antiglaucoma medications) and qualified success (with or without medications) were assessed at two target IOP levels, namely ≤21 and ≤17 mm Hg in both groups. Moreover, the success rates at ≤21 mm Hg target IOP level were compared with those from previous series of patients who had undergone DS without MMC (historical control group). Results: Data from all eyes were available until the 12th month. The mean preoperative IOP ± SD was 29.6 ± 5.8 mm Hg in DSMMC eyes, 28.0 ± 6.0 in TPMMC eyes; the mean IOP at the 1st postoperative day was 12.5 ± 4.2 and 13.9 ± 6.5 mm Hg, while at the endpoint the mean IOP was 14.5 ± 4.0 and 16.1 ± 3.8, respectively, with significant reduction (p < 0.0005) of the preoperative IOP in both groups. Complete success (≤21 mm Hg target IOP) in 15 eyes (78.9%) of the DSMMC group and in 15 eyes (71.4%) of the TPMMC group was respectively found, while qualified success was achieved in all the eyes. When a ≤17 mm Hg target IOP was considered, complete success in 12 eyes (63.1%) and 13 eyes (61.9%), and qualified success in 13 eyes (68.4%) and 15 eyes (71.4%) were found in the DSMMC and TPMMC groups, respectively. No significant intergroup differences were found in terms of success rate. There is no statistical significance in the Kaplan-Meier cumulative survival curves as for complete and qualified success rate in both surgical groups for a ≤17 mm Hg target IOP (log rank, p = 0.918 and p = 0.429, respectively). As for the frequency of postoperative complications, hypotony and shallow anterior chamber were significantly more frequent in TPMMC when compared with the DSMMC group. The historical comparison between the DSMMC group and simple DS cases shows no significant difference between the groups, with a mild positive trend in DSMMC when compared with DS eyes. Conclusions: Both techniques, DSMMC and TPMMC, control IOP efficaciously at our endpoint. Our results indicate that low-dosage MMC can be considered a mild enhancement of DS IOP lowering effect without any negative effect on the well-known intra- and postoperative safety of the technique.

Pharmacologic pupil dilation as a predictive test for the risk for intraoperative floppy-iris syndrome

PURPOSE: To evaluate the effect of α1‐adrenergic receptor antagonists (α1‐ARAs) on pupil diameter and determine whether the diameter predicts intraoperative floppy‐iris syndrome (IFIS). SETTING: Ophthalmology Section, Palermo University, Palermo, Italy. DESIGN: Prospective cohort study. METHODS: Male outpatients taking tamsulosin, α1‐ARAs, or no α1‐ARAs having phacoemulsification were recruited. Pupils were measured 1 month preoperatively, immediately preoperatively, and postoperatively under mesopic low (0.4 lux) and high (4.0 lux) illumination after pharmacologic dilation. The IFIS severity was graded. RESULTS: Each group comprised 50 patients. Pharmacologic dilation in both α1‐ARA groups was statistically significantly less than in the no α1‐ARA group 1 month preoperatively, immediately before surgery, and postoperatively (P=.001, P<.0005, and P<.0005, respectively). The IFIS incidence differed significantly between the tamsulosin and other α1‐ARA groups and the no α1‐ARA group (P<.0005 and P=.017, respectively) and between the tamsulosin group and the other α1‐ARA group (P=.027). On regression analysis, the hazard ratio for overall IFIS incidence was 3.8 in the other α1‐ARA group (P=.012) and 10.1 in the tamsulosin group (P<.0005). Pupil size was inversely related to IFIS incidence and severity (P<.0005). A dilated pupil of 7.0 mm or smaller had 73% sensitivity and 95% specificity for predicting IFIS (P=.0001). CONCLUSIONS: Pupil dilation was inhibited by α1‐ARAs, in particular tamsulosin. For a pupil 7.0 mm or smaller, the risk for IFIS existed regardless of α1‐ARAs treatment, which surgeons should take into consideration. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned.

Multifocal Choroiditis: Indocyanine Green Angiographic Features

The aim of this study is to retrospectively evaluate the indocyanine green (ICG) angiographic features in 13 patients affected by multifocal choroiditis. We identified two clinical and angiographic patterns. The ‘active’ pattern showed hypofluorescence up to the late phases and more extensive choroidal involvement than presumed by ophthalmoscopy and fluorescein angiography. In the ‘inactive’ pattern, ICG angiography showed hypofluorescence during all the phases: no increase in lesion number was observed between early and late phases. Choroidal neovascularization was present in 10 patients, and it was bilateral in 2 of these: it occurred only in the inactive stage. The appearance of choroidal lesions in IGC angiography supports the hypothesis of inflammatory involvement of the choriocapillaris as the pathophysiological mechanism of the disease.

Tonometers and infectious risk: myth or reality? Efficacy of different disinfection regimens on tonometer tips

PurposeTo evaluate the adequacy of common disinfection regimens for disposable tonometer tips and assess if disinfection of reusable prisms or the use of disposable tips is preferable.MethodsWe used disposable tonometer tips, using the same material and tip diameter of standard Goldmann tonometer prism. Strains of Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilisand Candida albicanswere tested according to the European standard guidelines for disinfectants test. Antimicrobial effectiveness of the following disinfection practices has been assessed: dry wipe, Minuten wipes (Alpro®), soaking in 3% hydrogen peroxide, 0.5% benzalkonium chloride, and 0.5% Pantasept® for 1, 5, and 15 min. All tests have been performed three times and all conditions tested in duplicate.ResultsDry wiping and 1 min soak in 3% hydrogen peroxide were ineffective on all microrganisms. Minuten wipes, 1 min soak in 0.5% benzalkonium chloride or 3% hydrogen peroxide were ineffective on B. subtilis. 0.5% Pantasept® soak was effective in 1 min for all microrganisms tested, whereas 3% hydrogen peroxide and 0.5% benzalkonium chloride soaks were effective when performed for at least 5 min. B. subtiliswas the most resistant organism to disinfectant regimes at 1 min time.ConclusionsResults of our study demonstrate a relative disinfection efficacy for the different evaluated regimens, provided that correct exposure times are adopted for the chosen disinfectants, a condition difficult to ensure in a busy clinic setting. We conclude that disposable prism tonometry provides a safe alternative to Goldmann tonometry.