A randomized controlled trial of alleviated positioning after small macular hole surgery. Comparison of face-down and seated position after idiopathic macular hole surgery: a randomized clinical trial. Heparin eyedrops to prevent posterior capsule opacification. Effect of posterior chamber intraocular lens design and surgical placement on postoperative outcome. The Madurai Intraocular Lens Study. II: Clinical outcomes. Randomised controlled trial of anterior-chamber intraocular lenses. Cataract surgery: interim results and complications of a randomised controlled trial. Oxford Cataract Treatment and Evaluation Team (OCTET). Impact of preoperative testing on ophthalmologic and systemic outcomes in cataract surgery. Morphological and functional results of AcrySof intraocular lens implantation in children: prospective randomized study of age-related surgical management.
To establish whether the success rate of surgery for small idiopathic macular holes (diameter, ≤ 400 μm) is significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position.
                Randomized, controlled, parallel-assignment, open-label, interventional, multicenter clinical trial.
                Sixty-nine patients from 6 specialized vitreoretinal units, randomized into 2 parallel groups and followed up after surgery for 3 months.
                All patients underwent pars plana vitrectomy, peeling of any epiretinal membrane, and 17% C₂F₆ gas filling. Patients then were advised randomly to observe either strict facedown positioning for 22 of 24 hours or simply to avoid the supine position for 10 days.
                The primary outcome measure was the rate of anatomic closure 3 months after surgery. Main secondary measurements included Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, progression of cataract, and frequency of complications.
                The mean size of macular holes was approximately 300 μm in both groups. Closure rates were more than 90% in both groups: 32 (91.4%) of 34 eyes in the alleviated positioning group versus 32 (94.1%) of 35 eyes in the facedown positioning group (lower margin of 95% confidence interval of difference, -14.88%). The ETDRS scores at 3 months increased in both groups by 10.23 ± 14.64 and 10.52 ± 14.54 letters, respectively. Progression of cataract and the rate of other complications were not significantly different in the 2 groups.
                The success rate of surgery for idiopathic macular holes of 400 μm or smaller is not significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position. These macular holes can be treated by streamlined surgery, that is, with no internal limiting membrane peeling and no facedown positioning (only avoidance of the supine position) with a closure rate of more than 90% and a mean gain in visual acuity of more than 2 ETDRS lines at 3 months.
                Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. To compare two therapeutic modalities on anatomic and functional results after idiopathic macular hole (MH) surgery: seated vs face-down position.
                Multicenter, prospective, randomized trial.
                Setting: University Hospital Dijon and University Hospital Nancy. Patients: One hundred and forty-four patients (150 eyes) were enrolled and randomly separated into two groups for postoperative position: for the 72 eyes in the P0 group and the 78 eyes in the P1 group, the patients were asked to keep the seated (P0 group) and the face-down position (P1 group) after the idiopathic MH surgery. Intervention: All patients underwent a complete vitrectomy with a fluid-air exchange and an intraocular gas tamponade. After the surgery, patients were asked to keep one of the two randomly chosen positions for five days. Main Outcome Measures: Best-corrected visual acuity (VA), fundus examination, and macular optical coherence tomography were performed before and six months after surgery.
                The overall anatomic success rate was 92.7%. The idiopathic MH sealed in 63 of 72 P0 eyes (87.5%) and 76 of 78 P1 eyes (97.4%) (P = .027). The mean VA increased from 0.86 to 0.61 logMAR (0.88 to 0.61 in P0 and 0.84 to 0.60 in P1). However, in a post hoc analysis based on the size of the idiopathic MH, the success rate in idiopathic MHs smaller than 400 microm was not influenced by the postoperative position (P = .47).
                A face-down postoperative position is highly recommended in holes larger than 400 microm. The size of the idiopathic MH seems to be an important factor affecting outcome. To evaluate whether heparin eyedrops prevent or reduce posterior capsule opacification (PCO) after extracapsular cataract extraction (ECCE) with intraocular lens (IOL) implantation.
                Institute of Ophthalmology, University G. d'Annunzio, Chieti, Italy.
                This 4 year, prospective, case-controlled study evaluated 200 patients who had ECCE and implantation of the same type of posterior chamber IOL. Patients were randomly assigned to receive topical heparin eyedrops postoperatively (heparin group, n = 100) or not to receive the eyedrops (control group, n = 100). Postoperative cell response, cellular precipitates on the IOL, and presence of PCO were evaluated.
                There were no significant differences between groups in postoperative inflammation. The incidence of cellular precipitates was significantly lower in the heparin group than in the control group (P < .001). A neodymium:YAG (Nd:YAG) posterior capsulotomy was done in 7 patients in the heparin group and 14 in the control group (P = .15). During the first 24 months after surgery, the heparin group had a significantly lower incidence of Nd:YAG capsulotomy (P < .05) and fibrotic PCO (P = .02).
                Topical heparin eyedrops were effective in reducing fibrotic PCO in the long term, indicating their usefulness in the postoperative management of ECCE. Intraocular lens (IOL) design, optical configuration, and placement have potential effects on postoperative outcome. Laboratory studies have suggested that one-piece, biconvex designs may reduce or delay posterior capsular opacification and that in-the-bag fixation of the posterior chamber IOL may reduce inflammation. To document the clinical significance of IOL design and placement, we conducted a randomized, prospective, clinical trial. Six hundred uncomplicated capsulorhexis and phacoemulsification patients were randomized in a three-factor design to receive an IOL that was one-piece or three-piece, had a biconvex, plano-convex, or laser ridge optic, and was bag-or sulcus-fixated. Treatment differences were related to lens placement. Patients with bag-fixated IOLs had less posterior capsular opacification, fewer YAG laser capsulotomies, a higher percentage of centered lenses, less inflammation, and fewer late posterior capsular striae than those with sulcus-fixated IOLs. In the latter group, patients with three-piece IOLs had fewer posterior capsular striae at three months postoperatively. All six occurrences of haptic loop distortion were in patients with three-piece IOLs. Patients with the one-piece design had less late inflammation than those with the three-piece design. Fewer YAG capsulotomies were necessary at one year in patients with the biconvex design than in those with the plano-convex or laser ridge configurations. Operative complications, endothelial cell loss, and postoperative complications were not IOL-related. To evaluate the safety and efficacy of extracapsular cataract extraction with posterior chamber intraocular lens (ECCE/PC-IOL) compared with intracapsular cataract extraction with aphakic glasses (ICCE-AG).
                In a nonmasked randomized controlled clinical trial, 3,400 bilaterally vision-impaired patients aged 40 to 75 years with operable cataract were randomly assigned to receive either ICCE-AG or ECCE/PC-IOL at the Aravind Eye Hospital in India. The surgery was performed by one of four study surgeons. Patients were hospitalized for 5 postoperative days, with follow-up visits at 2, 6, and 12 months after discharge. Postsurgery evaluations were conducted by two independent study ophthalmologists.
                At any single postoperative follow-up time point, there were no statistically significant differences of clinical relevance between treatment groups for any complication of a serious nature except cystoid macular edema, which was more common with ICCE (4.2% vs 1.6%). In general, whether of a trivial, intermediate, or serious nature, complication rates were low at each evaluation time point. Cumulatively, the incidence of serious complications of all types throughout the 1-year study period was 14.5% for patients in the ICCE-AG group and 7.7% in the ECCE group (P < .001). Best-corrected visual acuity of 20/40 or better at 12 months was attained by 90.7% of ICCE-AG patients and 96.3% of ECCE/PC-IOL patients (P < .001).
                Although both operative procedures are safe and effective for cataract patients with bilateral impairment, ECCE/PC-IOL is superior to ICCE-AG in terms of both visual acuity restoration and safety. There are an estimated 16 million people blind in both eyes with cataracts. Most live in rural areas of developing countries where surgical resources are scarce. There is no consensus on the most appropriate type of intraocular lens in situations where high-volume low-cost surgery is required. This study was undertaken to evaluate the safety of multiflex open-loop anterior-chamber lenses (ACIOLs).
                2000 people attending Lahan Eye Hospital, southern Nepal, with bilateral cataracts reducing vision to 6/36 or less were randomly allocated to receive standard surgery--intracapsular extraction (ICCE) with aphakic correction--or ICCE with an ACIOL in their first operated eye. The primary outcome was a visual acuity of less than 6/60 in the operated eye at 1 year follow-up. Visual acuity was measured for 91% of the cohort at 1 year. The sample size was estimated to detect a doubling in poor visual outcome from an estimated rate of 4% in the standard surgery (control) group.
                The median (range) time taken to do the surgery was 6.0 (3.0-17.2) min for the ACIOL group and 4.1 (2.4-10.3) min for the control group. 1 year after surgery, 5.0% of the ACIOL group and 5.4% of controls had functional vision less than 6/60 (OR 0.93 [0.60-1.43], p = 0.71). The causes of poor vision in the ACIOL and control groups were: correctable refractive error (22 and 29), uveitis/secondary glaucoma (13 and two), endophthalmitis (four and seven), pre-existing eye disease (four and five), retinal detachment (none and four), cystoid macular oedema (two and none), corneal ulcer (one and one), and corneal decompensation (none and one).
                This study provides evidence that, in rural areas of developing countries, multiflex open-loop ACIOLs can be implanted safely by experienced ophthalmologists after routine ICCE, avoiding the disadvantages of aphakic spectacle correction. Further follow-up is planned. A randomised controlled trial in progress for more than five years, with no loss to follow-up (except death), assessed 333 eyes treated by three methods of cataract surgery. They were (A) intracapsular extraction and contact lens usage, (B) intracapsular extraction and implantation of an iris supported lens (Federov I), and (C) extracapsular extraction and implantation of an iridocapsular lens (Binkhorst 2-loop). The purpose of the paper is to report interim visual results, complications, and corneal endothelial cell loss. More eyes in groups A (contact lens) and C (extracapsular + implant) achieved better visual acuity than in group B (intracapsular + Federov lens), which also had more postoperative complications. Both implant groups lost more endothelial cells than the non-implant group, which did not differ significantly from group B before one year. To evaluate the incidence of ophthalmologic and systemic complications in patients who undergo cataract surgery without preoperative tests compared to subjects undergoing cataract surgery preceded by preoperative tests.
                The randomized controlled study included 1276 consecutive patients admitted to the Institute of Ophthalmology of the University of Modena and Reggio Emilia for cataract surgery. The patients were randomly divided into two groups: 638 were assigned not to undergo preoperative evaluation based on routine medical tests and electrocardiograms; the other 638 underwent preoperative evaluation based on said tests. Ophthalmologic and systemic complications were assessed intraoperatively and 1 month after surgery.
                Eleven intraoperative complications occurred in the group without preoperative tests and eight in the group with preoperative tests; at 1 month six complications were recorded in the group without tests and five in the group with tests. Systemic adverse events occurred intraoperatively in four patients, whereas no systemic adverse event was recorded at 1 month in either group. No statistically significant differences were observed between the two groups.
                The findings of this study have broad applicability, because the sample is representative of the population existing in numerous social and healthcare settings; they are of value for administrative purposes, because they may be taken as reference in resource allocation plans; and they have medicolegal implications, as the resulting conduct of healthcare providers is supported by a rigorous scientific study. To evaluate the prevalence and severity of posterior capsule opacification (PCO) in pediatric eyes with a foldable acrylic AcrySof (Alcon) intraocular lens (IOL) and age-related surgical methods.
                Department of Ophthalmology, University of Vienna, Medical School, Vienna, Austria.
                This prospective randomized study comprised 50 eyes of 34 children aged between 2 and 16 years. Eyes of children between 2 and 5.9 years were consecutively randomized to Group 1a (primary posterior capsulotomy and anterior vitrectomy) or Group 1b (optic capture in addition). Eyes of children between 6 and 16 years were consecutively randomized to Group 2a (primary posterior capsulotomy without anterior vitrectomy), Group 2b (optic capture in addition), or Group 2c (in-the-bag IOL implantation without opening the posterior capsule). Main outcome parameters were the incidence and severity of PCO formation, early postoperative complications, pigmented cell deposits on the IOL surface, and cataract morphology.
                The visual axis was clear at the last follow-up in all eyes in Groups 1a, 1b, 2a, and 2b except in 1 eye in Group 1a. Sixty-percent of eyes in Group 2c had PCO. The incidence of early postoperative complications was significantly higher in eyes that developed PCO than in those that maintained a clear visual axis. There was no evidence that cataract morphology influenced PCO rates.
                The AcrySof IOL was well tolerated in pediatric eyes. Optic capture was not necessary to ensure a clear visual axis. Primary posterior capsulotomy should be performed in preschool and uncooperative children and in eyes expected to have relatively high postoperative inflammation. Implanting the AcrySof in the bag and leaving the posterior capsule intact is acceptable for school children and juveniles with isolated developmental cataract.
There is currently insufficient evidence from which to draw firm conclusions about the impact of postoperative face-down positioning on the outcome of surgery for macular hole. Of three RCTs, two suggested a benefit in larger holes but none demonstrated evidence of a benefit in smaller holes.
CONSORT adherent RCTs and large scale, well designed non-randomised observational studies are needed to determine with confidence the value of this intervention.