Cataract surgery in high-risk age-related macular degeneration: a randomized controlled trial. Impact of preoperative testing on ophthalmologic and systemic outcomes in cataract surgery. The Madurai Intraocular Lens Study. II: Clinical outcomes. Randomised controlled trial of anterior-chamber intraocular lenses. Extracapsular cataract surgery compared with manual small incision cataract surgery in community eye care setting in western India: a randomised controlled trial. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: ophthalmic findings: SST report no. 13. Visual outcome of conventional extracapsular cataract extraction with posterior chamber intraocular lens implantation versus manual small-incision cataract surgery. [Comparison of complications after intra- and extracapsular cataract extraction with lens implantation. Results of a prospective, randomized, clinical study].
To investigate if cataract surgery causes progression, from high-risk early age-related macular degeneration (AMD) to choroidal neovascularization (CNV), in the postoperative period.
                Randomized controlled trial. Patients, with visually significant cataract and fundus features of early AMD at high risk of progression to CNV, were randomized into two groups and were evaluated at baseline and 6 months. The study patients (n = 27) underwent immediate cataract surgery. The control group (n = 29) comprised patients who had cataract surgery deferred until after the 6-month visit. Assessment included visual acuity, quality of life (QoL) and fundus fluorescein angiography (FFA).
                Of 68 eligible eyes, 60 participated and 56 completed the study. Three referred eyes (3.2%) were ineligible on the basis of a pre-existing, unsuspected occult CNV that was detected by baseline FFA. All three cases had end-stage exudative AMD in the fellow eye. Of the study eyes in the immediate surgery arm (n = 27), one (3.7%) developed CNV compared with none (0/29) in the deferred arm (chi(2); P = 1.0) at 6 months. In the operated group, there was a 2.8-line improvement in logMAR visual acuity and 2.1-fold average gain in QoL at 6 months.
                No increased short-term risk of progression of AMD to CNV in high-risk fundi following uncomplicated phacoemulsification surgery was found. A low threshold for performing preoperative imaging in patients with AMD, especially in those with exudative AMD in the fellow eye, to exclude undetected CNV is recommended. Provided there is no CNV, there are distinct benefits of cataract surgery in people with early AMD. 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 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. To study "manual small incision cataract surgery (MSICS)" for the rehabilitation of cataract visually impaired and blind patients in community based, high volume, eye hospital setting; to compare the safety and effectiveness of MSICS with conventional extracapsular cataract surgery (ECCE).
                In a single masked randomised controlled clinical trial, 741 patients, aged 40-90 years, with operable cataract were randomly assigned to receive either MSICS or ECCE and operated upon by one of eight participating surgeons. Intraoperative and postoperative complications were graded and scored according to the Oxford Cataract Treatment and Evaluation Team recommendations. The patients were followed up at 1 week, 6 weeks, and 1 year after surgery and their visual acuity recorded.
                This paper reports outcomes at 1 and 6 weeks. 706 of the 741(95.3%) patients completed the 6 week follow up. 135 of 362 (37.3%) of ECCE group and 165 of 344 (47.9%) of MSICS group had uncorrected visual acuity of 6/18 or better after 6 weeks of follow up. 314 of 362 (86.7%) of ECCE group and 309 of 344 (89.8%) of MSICS group had corrected postoperative vision of 6/18 or better. Four of 362 (1.1%) of ECCE group and six of 344 (1.7%) of MSICS group had corrected postoperative visual acuity less than 6/60. There were no significant differences between the two groups for intraoperative and severe postoperative complications.
                MSICS and ECCE are both safe and effective techniques for treatment of cataract patients in community eye care settings. MSICS needs similar equipment to ECCE, but gives better uncorrected vision. To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS).
                Randomized clinical trial.
                Six hundred seven newly diagnosed glaucoma patients.
                In a randomized clinical trial, 607 patients with newly diagnosed open-angle glaucoma were initially treated with either medication or trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up, patients were evaluated clinically at 6-month intervals. In addition, quality of life telephone interviews were conducted at similar frequency to the clinical visits. Patients in both arms of CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined target pressure specific for each individual eye. Visual field (VF) scores were analyzed by time-specific comparisons and by repeated measures models.
                VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied.
                On the basis of completed follow-up through 4 years and partially completed through 5 years, VF loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical patients had a greater risk of substantial VA loss compared with medical patients. However, by 4 years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The rate of cataract requiring removal was greater in the surgically treated group.
                Both initial medical or initial surgical therapy result in about the same VF outcome after up to 5 years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to be converging as follow-up continues. When aggressive treatment aimed at substantial reduction in IOP from baseline is used, loss of VF can be seen to be minimal in general. Because 4 to 5 years of follow-up in a chronic disease is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches to open-angle glaucoma. To present best-corrected visual acuity (BCVA) findings and other clinical outcomes from eyes of patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of predominantly hemorrhagic subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration.
                Randomized clinical trial (SST Group B Trial).
                Eligible patients had subfoveal choroidal neovascular lesions greater than 3.5 disk areas (8.9 mm2) composed of at least 50% blood (either blood or CNV underlying the center of the foveal avascular zone) and BCVA of 20/100 to light perception in the study eye.
                Patients were assigned randomly at time of enrollment to observation or surgical removal of blood and any associated CNV.
                A successful outcome was defined a priori as either improvement in visual acuity (VA), no change in VA, or a decline in VA of no more than 1 line (7 letters) from baseline to the 24-month examination based on an intent-to-treat analysis.
                Of 336 patients enrolled, 168 were assigned to each treatment arm; treatment arms were balanced by baseline characteristics. Of 1501 expected examinations 3 months through 36 months after baseline, 1370 (91%) were performed. Loss of > or =2 lines (> or =8 letters) of VA occurred in 56% of surgery eyes, versus 59% of observation eyes examined at 24 months. Although severe loss of VA was not the primary outcome of interest, surgery more often prevented such loss: 36% in the observation arm versus 21% in the surgery arm at the 24-month examination (chi2 P = 0.004). Of initially phakic eyes, the cumulative percentage that had undergone cataract surgery by 24 months was 44% in the surgery arm, compared with 6% in the observation arm. Twenty-seven eyes (16%) in the surgical arm, compared with 3 eyes (2%) in the observation arm, had a rhegmatogenous retinal detachment (RD).
                Submacular surgery as performed in the SST Group B Trial did not increase the chance of stable or improved VA (the primary outcome of interest) and was associated with a high risk of rhegmatogenous RD, but did reduce the risk of severe VA loss in comparison with observation. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha. an effective method for cataract surgery should be identified to combat cataract blindness.
                to study the surgical outcome of conventional extracapsular cataract extraction versus manual small-incision cataract surgery.
                a randomized clinical trial was carried out including one hundred eyes (88 patients) which were divided into two groups using systematic randomization: groups of conventional extracapsular cataract extractionwith posterior chamber intraocular lens (ECCE with PCIOL) implantation and manual small-incision cataract surgery (MSICS). The postoperative parameters/variables studied were the unaided and best-corrected visual acuity and astigmatism.
                epi info 2000 version statistical software was used for data analysis and calculation of relative risk, 95% CI and p value. The p value of less than 0.05 was considered as significant.
                in the immediate postoperative period, unaided visual acuity of =or> 6/18 was achieved in 24 subjects in MSICS group versus 7 in ECCE with PCIOL group (RR=2.05, 95% CI= 1.44 - 2.94, p = 0.0002), whereas the same at 6 - 8 weeks postoperatively was found in 28 and 22 subjects in those groups respectively (RR=1l.27, 95% CI=0.86-1.89, p=0.23). The astigmatism of =or> 2 at6 - 8 weeks was found in 35 and 17 subjects from the conventional and MSICS groups respectively ( R=2.28, 95% CI= 1.39-3.73, p=0.0002).
                both MSICS and conventional ECCE with PCIOL are safe and effective techniques for treatment of cataract patients. A more rapid recovery of good vision can be achieved with MSICS than with conventional ECCE with PCIOL in the immediate postoperative period. The postoperative complications of ICCE with ACL implantation are compared with those of ECCE and PCL. Our clinical experience with ICCE and ACL implantation can not confirm the widespread rejection of this method.
                A prospective, randomized, clinical study with participation of medical statisticians was performed. A total of 190 patients with ICCE and ACL and 170 patients with ECCE and PCL were followed up for 2 years. The follow-up examinations were performed upon dismission from the hospital, after 6, 12 and 24 months. The data were compiled in a computer program designed for this study and evaluated by the statisticians. The surgical procedures and the surgeons were defined prior to the beginning of patient recruitment.
                ICCE with ACL shows much less postoperative complications as usually emphasized. There were only 2 (1.2%) of retinal detachment and no case of corneal decompensation. Cystoid macular edema 8 (4.7%), postoperative vitreous prolaps into the anterior chamber 4 (2.3%) and spontaneous complaints of pain 16 (9.4%) occurred in a low percentage after ICCE with ACL. These complications did not occur after ECCE with PCL. The patients with ECCE and PCL showed capsular fibrosis in 48 (28%) making it the most frequent complication of the whole study. 33% of these patients required YAG-laser capsulotomy. Since retinal detachment occurs in 2.5% after YAG-laser capsulotomy we can not regard capsular fibrosis as a totally harmless complication. It is noteworthy that visual acuity is almost identical 1 year after surgery in both methods.
                The results of this study show that the evaluation of ICCE with ACL is too negative. The elimination of postoperative complications in this method is more difficult. ECCE with PCL is burdened by frequent capsular fibrosis. Visual acuity is almost the same in both methods 1 years after the operation. ACL-implantation remains our method of choice for secondary implantation in patients with an intact iris diaphragm.
At this time, it is not possible to draw reliable conclusions from the available data to determine whether cataract surgery is beneficial or harmful in people with AMD. Physicians will have to make practice decisions based on best clinical judgment until controlled trials are conducted and their findings published.
It would be valuable for future research to investigate prospective RCTs comparing cataract surgery to no surgery in patients with AMD to better evaluate whether cataract surgery is beneficial or harmful in this group. However ethical considerations need to be addressed when delaying a potentially beneficial treatment and it may not be feasible to conduct a long-term study where surgery is withheld from the control group. Utilization of pre-existing, standardized systems for grading cataract and AMD and measuring outcomes (visual acuity, change in visual acuity, worsening of AMD and quality of life measures) should be encouraged.