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Early DMO: a predictor of poor outcomes following cataract surgery in diabetic patients. The DICAT-II study.

ABSTRACT: The prospective DIabetes and CATaract Study II (DICAT II) was performed to characterise the risks of cataract surgery to the retinae of patients with early diabetic macular oedema (E-DMO). DICAT II was a prospective, comparative, multicentre, observational study involving six Italian clinics. Patients were aged ≥55 years, had type 1 or 2 diabetes with spectral-domain optical coherence tomography evidence of ESASO classification Early DMO. Group 1 eyes (78 eyes, 78 patients) underwent phacoemulsification-based cataract surgery. Group 2 eyes (65 eyes, 65 patients) had E-DMO and either clear media or had undergone uncomplicated cataract surgery ≥1 year previously. Central subfield thickness (CST) and best-corrected visual acuity (BCVA) were assessed in both groups. The negative impact of surgery on CST was evident after the first postoperative week; CST peaked during the first month, then rapidly decreased. CST worsening ≥10 µm was observed in 63/78 eyes (80.7%) and 29/65 eyes (44.6%) in Groups 1 and 2, respectively (p < 0.0001). CST worsening of ≥50 µm was observed in 51 eyes (65.4%) and 10 eyes (15.4%) in Groups 1 and 2, respectively (p < 0.0001). Mean CST worsening was lower in Group 2 than in Group 1 (38.6 ± 30.4 µm vs 85.5 ± 55.3 µm, p < 0.0001) with a lower BCVA loss (-2.6 ± 3.5 letters vs -8.2 ± 6.2 letters, p < 0.0001). Higher glycaemic levels and HBA1c levels were significantly associated with the risk of >50 μm CST worsening in eyes from both groups. Early DMO is associated with poorer outcomes after cataract surgery and requires close pre- and postoperative monitoring.

SUBMITTER: Panozzo G

PROVIDER: S-EPMC8330474 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe purpose of this study was to evaluate nepafenac ophthalmic suspension 0.1% (Nevanac(®); Alcon Research Ltd) in the prevention of macular edema following cataract surgery in diabetic retinopathy patients.MethodsThis was a multicenter, randomized, double-masked, vehicle-controlled study of 263 adult diabetic patients with nonproliferative diabetic retinopathy requiring cataract surgery. Patients were randomized (1:1) to instill nepafenac or vehicle three times daily beginning 1 day prior to surgery through day 90. Efficacy included the percentage of patients who developed macular edema (≥30% increase in central subfield macular thickness from baseline) and the percentage of patients with decreases of more than five letters in best-corrected visual acuity from day 7 to 90.ResultsA significantly lower percentage of patients in the nepafenac group developed macular edema relative to patients in the vehicle group (3.2% versus 16.7%; P < 0.001). A significantly lower percentage of patients in the nepafenac group had best-corrected visual acuity decreases of more than five letters relative to patients in the vehicle group on day 30 (P < 0.001), day 60 (P = 0.002), and day 90 (P = 0.006). The mean central subfield macular thickness and mean percent change from baseline in macular volume were also significantly lower in the nepafenac group versus the vehicle group at days 14 through 90 (P ≤ 0.005). No safety issues or trends were identified when dosing was increased to 90 days that negatively impacted the favorable benefit/risk profile of nepafenac.ConclusionNepafenac demonstrated statistically significant and clinically relevant advantages compared with vehicle in preventing macular edema and maintaining visual acuity in diabetic patients following cataract surgery. These advantages were seen at multiple time points over the course of the 90-day therapy period. There was no clinically relevant increase in risk from 90 days dosing compared with 14 days. Therefore, with a similar safety profile and benefit in preventing macular edema and maintaining vision, the risk/benefit to the diabetic patient undergoing cataract surgery appears to be positive.

Project description:PurposeTo report visual outcomes and risk factors for poor outcomes of cataract surgery in three Integrated Tribal Development Agency (ITDA) areas of Andhra Pradesh, India.Methods and resultsUsing validated Rapid Assessment of Avoidable Blindness (RAAB) methodology, a population based cross-sectional study, was conducted in three ITDA areas. A two-stage sampling procedure was used to select 7281 participants aged 50 years and above. Vision assessment using a tumbling E chart and standard ocular examinations were completed. Visual outcomes and risk factors for poor outcomes were assessed among subjects undergoing cataract surgery (1548 eyes of 1124 subjects). Mean age at surgery was 67±8 years; Among the operated eyes, presenting visual acuity (PVA) and best corrected visual acuity (BCVA) worse than 6/18 was seen in 492 (31.8%; 95% CI, 29.5-34.2%) and 298 eyes (19.3%; 95% CI, 17.3-21.3%), respectively. Similarly, PVA and BCVA worse than 6/60 was seen in 219 (14.1%; 95% CI, 12.4-16%) and 147 eyes (9.5%; 95% CI, 8.1-11.1%), respectively. When either eye was taken into consideration, the PVA and BCVA worse than 6/18 was seen in 323 (20.1%; 95% CI, 18.9-23%) and 144 subjects (9.3%; 95% CI, 7.9-10.9%), respectively. PVA and BCVA worse than 6/60 was seen in 74 (4.8%; 95% CI, 3.8-6%) and 49 subjects (3.2%; 95% CI, 2.4-4.2%), respectively. Posterior capsular opacification was seen in 51 of 1316 pseudophakic eyes (3.9%; 95% CI, 2.9-5.1%). In multivariable analysis among pseudophakic subjects with PVA worse than 6/18, increasing age (p?=?0.002) and undergoing free surgery (p?=?0.05) were independent risk factors. Undergoing surgery before 2005 (p?=?0.05) and being illiterate (p?=?0.05) were independent risk factors for BCVA worse than 6/18.ConclusionsThere are changing trends with improved outcomes in cataract surgery among these tribal populations of India. However, post-operative refractive error correction remains an issue, especially for those undergoing free surgeries.

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Early DMO: a predictor of poor outcomes following cataract surgery in diabetic patients. The DICAT-II study.

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