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Macular Edema After Cataract Surgery in Eyes Without Preoperative Central-Involved Diabetic Macular Edema

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Macular Edema After Cataract Surgery in Eyes Without Preoperative Central-Involved Diabetic Macular Edema Research Original Investigation | CLINICAL SCIENCES Macular Edema After Cataract Surgery in Eyes Without Preoperative Central-Involved Diabetic Macular Edema Diabetic Retinopathy Clinical Research Network Authors/Writing Committee* Journal Club Slides and IMPORTANCE The incidence of development or worsening of macular edema (ME) is variable Supplemental content at in eyes without diabetic ME (DME) undergoing cataract surgery. jamaophthalmology.com OBJECTIVE To estimate the incidence of central-involved ME 16 weeks following cataract surgery in eyes with diabetic retinopathy without definite central-involved DME preoperatively. DESIGN, SETTING, AND PARTICIPANTS In a multicenter, prospective, observational study, 293 participants with diabetic retinopathy without definite central subfield thickening on optical coherence tomography (OCT) underwent cataract surgery. EXPOSURE Cataract extraction surgery performed within 28 days of enrollment of eyes without DME in individuals with diabetes mellitus. MAIN OUTCOMES AND MEASURES Development of central-involved ME defined as the following: (1) OCT central subfield thickness of 250 μm or greater (time-domain OCT) or 310 μm or greater (spectral-domain OCT) with at least a 1-step increase in logOCT central subfield thickness preoperatively to the 16-week visit; (2) at least a 2-step increase in logOCT central subfield thickness preoperatively to the 16-week visit; or (3) nontopical treatment for ME received before the 16-week visit with either of the OCT criteria met at the time of treatment. RESULTS The median participant age was 65 years. The median visual acuity letter score was 69 letters (Snellen equivalent 20/40). Forty-four percent of eyes had a history of treatment for DME. Sixteen weeks postoperatively, central-involved ME was noted in 0% (95% CI, 0%-20%) of 17 eyes with no preoperative DME. Of eyes with non–central-involved DME, 10% (95% CI, 5%-18%) of 97 eyes without central-involved DME and 12% (95% CI, 7%-19%) of 147 eyes with possible central-involved DME at baseline progressed to central-involved ME. History of DME treatment was significantly associated with central-involved ME development (P < .001). CONCLUSIONS AND RELEVANCE In eyes with diabetic retinopathy without concurrent central-involved DME, presence of non–central-involved DME immediately prior to cataract surgery or history of DME treatment may increase the risk of developing central-involved ME 16 weeks after cataract extraction. *Authors/Members Writing Committee and Investigators are listed at the end of this article. Group Information: A complete list of the Diabetic Retinopathy Clinical Research Network appears in the Supplement. Corresponding Author: Talat Almukhtar, MBChB, Jaeb Center for Health Research, 15310 Amberly Dr, JAMA Ophthalmol. 2013;131(7):870-879. doi:10.1001/jamaophthalmol.2013.2313 Ste 350, Tampa, FL 33647 (drcrstat6 Published online April 18, 2013. @jaeb.org). 870 jamaophthalmology.com Downloaded From: https://jamanetwork.com/ on 09/30/2021 Macular Edema After Cataract Surgery Original Investigation Research iabetes mellitus increases the probability of develop- cal examination. Eyes with major ocular surgery in the prior ing cataract and may increase the risk of reduced vi- 4 months and eyes with an ocular condition (other than cata- D sual outcomes after cataract surgery.1,2 As approxi- ract or DME) that might affect VA during the course of the study mately 250 000 people with diabetes in the United States were excluded. Only 1 eye from each study participant was en- undergo cataract surgery each year, improvements in under- rolled. standing the prognosis and management of these cases could confer a substantial benefit to many people.3 Study Design Past studies on patients with diabetes undergoing cata- Study participants were enrolled by investigators at partici- ract removal using intracapsular and extracapsular cataract ex- pating DRCR.net clinical sites certified by the coordinating cen- traction techniques suggest that cataract surgery is a risk fac- ter in this protocol. Participants were either identified by a par- tor for incidence of macular edema (ME) or worsening of ticipating retina specialist and referred to the cataract surgeon diabetic retinopathy.4-6 Some reports suggest that ME after or identified by a cataract surgeon and referred to the retina cataract surgery and in people with diabetes may occur pre- specialist for enrollment. As the actual cataract surgery was dominantly in people with concurrent preexisting diabetic ME not part of the experimental design, the cataract surgeons were (DME) involving the center of the macula. However, other re- not considered investigators for this protocol. The cataract sur- ports indicate that preexisting DME is not needed for ME to gery, including preoperative and postoperative assessments occur postoperatively.7 These studies, though, were com- and management, was conducted by and according to the cata- pleted prior to the availability of optical coherence tomogra- ract surgeon’s usual routine. With study participant permis- phy (OCT) technology. The use of OCT can provide both quali- sion, the DRCR.net clinical center obtained the surgical pro- tative and quantitative data to explore the relationship of ME cedure report and postoperative records from the cataract and cataract surgery in patients with diabetic retinopathy. surgeon for data collection. The Diabetic Retinopathy Clinical Research Network (DR- Protocol study-related visits were specified as preopera- CR.net) conducted an observational study to evaluate the in- tive baseline visit (performed ≤28 days preceding surgery), cidence of central-involved ME, as defined by OCT, in eyes 4-week post–cataract surgery visit, and 16-week post– without definite central-involved DME immediately prior to cataract surgery visit. These visits were conducted at DR- cataract surgery. In addition, factors associated with develop- CR.net clinical sites by certified investigators and personnel. ment of central-involved ME are explored. At all visits, procedures included protocol refraction, best- corrected electronic ETDRS VA test (E-ETDRS),9 fundus ex- amination, and OCT of the study eye following a standard- Methods ized protocol. When the metrics describing retinal thickness generated by OCT software were suspected to be erroneous by This prospective, noncomparative, multicenter, observa- the clinical site or when the ratio of center-point thickness stan- tional study was conducted by the DRCR.net at 45 clinical sites dard deviation to the mean center point thickness from TD- throughout the United States. The protocol and Health Insur- OCT Stratus scans was more than 10.5%, scans were for- ance Portability and Accountability Act–compliant informed warded to a central OCT reading center (Duke Reading Center, consent forms were approved by the institutional review board Duke University, Durham, North Carolina) for grading; other- for each participating site. Each participant gave written in- wise, the automated OCT thickness measurements were used formed consent to participate in the study. The study proto- for analyses. col (named “An Observational Study in Individuals With Dia- The DME status at baseline was categorized into 4 catego- betic Retinopathy Without Center-Involved DME Undergoing ries according to machine- and gender-specific retinal thick- Cataract Surgery”) is available on the DRCR.net website (drcr ness values in the CSF and non-CSF from the OCT map (Table 1). .net) and summarized here. • No DME was defined as thickness in each subfield less than the mean thickness from a diabetic cohort without DME. Study Population • Possible DME in the CSF was defined as thickness between Eligible study participants were at least 18 years of age with the mean and the mean + 2 SDs from a diabetic cohort with- type 1 or type 2 diabetes and were receiving cataract surgery out DME. in an eye with diabetic retinopathy but without definite central- • Possible non–central-involved DME was defined as thick- involved DME. Eyes were eligible provided the following cri- ness of at least 1 non-CSF between the mean and the mean + 2 teria were met: (1) presence of cataract for which cataract sur- SDs from a diabetic cohort without DME. gery was scheduled within 28 days of study enrollment; (2) • Definite non–central-involved DME was defined as thick- visual acuity (VA) of light perception or better; (3) OCT cen- ness of at least 1 non-CSF more than the mean + 2 SDs from tral subfield (CSF) thickness less than 250 μm on time- a diabetic cohort without DME. domain OCT (TD-OCT) (Stratus [Carl Zeiss Meditec]) or less than Any intervention performed on the study eye during the 310 μm on spectral-domain OCT (SD-OCT) (Cirrus [Carl Zeiss 16-week course of the study was at the discretion of the cata- Meditec], Spectralis [Heidelberg], or Optovue RTVue [Opt- ract surgeon or the DRCR.net investigator. When and if treat- ovue]); and (4) presence of microaneurysms or at least mild ment for ME, other than topical medications, was given by the nonproliferative diabetic retinopathy (Early Treatment Dia- investigator for the first time postoperatively, best-corrected betic Retinopathy Study [ETDRS] level 20 or higher8) on clini- E-ETDRS VA, OCT, and fluorescein angiography were per- jamaophthalmology.com JAMA Ophthalmology July 2013 Volume 131, Number 7 871 Downloaded From: https://jamanetwork.com/ on 09/30/2021 Research Original Investigation Macular Edema After Cataract Surgery Table 1. Baseline and Outcome
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