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Effect of preoperative use of topical prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery: a randomized trial.

ABSTRACT: To compare the effects of preoperative use of topical anti-inflammatory prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery.Randomized clinical trial.This single-center, masked, randomized clinical study comprised 140 patients scheduled for cataract surgery. Patients (35 in each group) were randomized to receive placebo, prednisolone acetate, ketorolac tromethamine 0.4% or nepafenac. These eye drops were administered three times daily for the two days prior to surgery. The pupillary diameters were measured by the surgeon using a compass prior to the corneal section and at the end of surgery. The primary outcome was the number of patients with pupil ? 6mm at the end of the surgery; the secondary outcome was the number of patients with pupil ? 6mm at the beginning of the surgery.All the patients achieved pupil ? 6mm at the beginning of the surgery. The number of patients in the prednisolone (29/35), nepafenac (31/35) and ketorolac (30/35) groups with pupil ? 6mm was greater than in the placebo group in the maintenance of intraoperative mydriasis (19/35 - P =0.003). There was no statistical difference among the prednisolone, nepafenac and ketorolac groups in the maintenance of intraoperative mydriasis (P =.791). There were no complications during surgery or related to the preoperative use of the eye drops.Preoperative use of ketorolac, prednisolone and nepafenac was effective in maintaining intraoperative mydriasis when compared with placebo.

SUBMITTER: Zanetti FR

PROVIDER: S-EPMC3442462 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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Effect of preoperative use of topical prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery: a randomized trial.

Zanetti Fernando Roberte FR Fulco Enzo Augusto Medeiros EA Chaves Fernando Rodrigo Pedreira FR da Costa Pinto Alexandre Paashaus AP Arieta Carlos Eduardo Leite CE Lira Rodrigo Pessoa Cavalcanti RP

Indian journal of ophthalmology 20120701 4

<h4>Purpose</h4>To compare the effects of preoperative use of topical anti-inflammatory prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery.<h4>Design</h4>Randomized clinical trial.<h4>Materials and methods</h4>This single-center, masked, randomized clinical study comprised 140 patients scheduled for cataract surgery. Patients (35 in each group) were randomized to receive placebo, prednisolone acetate, ketoro ...[more]

PMID: 22824596

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Project description:ImportanceThe choice of anti-inflammatory prophylaxis parallel to cataract surgery is important for patient safety and successful outcome of surgery, but which regimen to choose is contested.ObjectivesTo determine whether a combination of prednisolone and nonsteroidal anti-inflammatory drug (NSAID) eye drops was superior in preventing increased central macular thickness (central subfield thickness [CST]) after uncomplicated cataract surgery compared with NSAID monotherapy and sub-Tenon capsule depot (dropless surgery), and to test whether preoperative initiation of eye drop treatment was superior to initiation on the day of surgery.Design, setting, and participantsThis investigator-driven, single-center, randomized clinical trial with masked statistical analyses enrolled patients at the Department of Ophthalmology, Rigshospitalet Glostrup, Glostrup, Denmark, from February 1, 2018, to August 15, 2019. Follow-up was completed December 18, 2019. Participants included low-risk patients undergoing phacoemulsification for age-related cataract by an experienced surgeon (1 eye per participant). Data were analyzed from February 17 to June 15, 2020.InterventionsParticipants scheduled for cataract removal were randomized to 1 of 5 anti-inflammatory prophylactic regimens: eye drops with a combination of prednisolone, 1%, and ketorolac tromethamine, 0.5%, with or without preoperative initiation (preoperative prednisolone plus NSAID [control] and postoperative prednisolone plus NSAID groups), ketorolac monotherapy with or without preoperative initiation (preoperative and postoperative NSAID groups), or sub-Tenon depot of dexamethasone phosphate (sub-Tenon group). Eye drops were administered 3 times per day until 3 weeks postoperatively.Main outcomes and measuresCST 3 months postoperatively.ResultsA total of 470 participants (mean [SD] age, 72.2 [7.0] years; 290 women [61.7%]) with 94 participants in each group were included in the analysis. Three months after surgery, the mean CST was 250.7 (95% CI, 247.6-253.7) μm in the preoperative prednisolone plus NSAID group, 250.7 (95% CI, 247.8-253.7) μm in the postoperative prednisolone plus NSAID group, 251.3 (95% CI, 248.2-254.4) μm in the preoperative NSAID group, 249.2 (95% CI, 246.2-252.3) μm in the postoperative NSAID group, and 255.2 (95% CI, 252.0-258.3) μm in the sub-Tenon group. There were no significant differences in CST or visual acuity compared with control and no differences between preoperative and postoperative groups, but 47 of 83 participants (56.6%) in the sub-Tenon group needed additional anti-inflammatory treatment.Conclusions and relevanceNo differences in CST or visual acuity were detected between the combination of prednisolone and NSAID eye drops vs NSAID monotherapy or sub-Tenon dexamethasone depot, although more than one-half of patients in the sub-Tenon arm received additional anti-inflammatory treatment. Initiating prophylaxis 3 days preoperatively was not superior to initiation on the day of surgery. Monotherapy with NSAIDs may be preferred in uncomplicated cataract surgery.Trial registrationClinicalTrials.gov Identifier: NCT03383328.

Project description:OBJECTIVE:Topical steroids are the cornerstone in controlling the inflammation after cataract surgery. Prednisolone acetate and difluprednate are the two main products for this purpose. However, it is unclear which one should be used in terms of effectiveness and safety. DESIGN:Systematic review and meta-analysis. DATA SOURCES:Medline via PubMed, Cochrane Central Register of Controlled Trials, Web of science and clinicaltrials.gov were searched through 10 January 2018, and updated on 20 July 2019, in addition to researching the references' lists of the relevant articles. ELIGIBILITY CRITERIA:Randomised-controlled trials (RCTs) comparing difluprednate and prednisolone acetate regardless of the dosing regimen used. DATA EXTRACTION AND SYNTHESIS:Two independent authors assessed the included RCTs regarding the risk of bias using the Cochrane tool. Relevant data were extracted, and meta-analysis was conducted using a random-effects model. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to appraise the evidence quality. RESULTS:We included six RCTs with 883 patients: 441 received difluprednate and 442 received prednisolone acetate. The evidence quality was graded as moderate for corneal oedema and intraocular pressure and low for anterior chamber (AC) clearance. After small incision cataract surgery, difluprednate was superior in clearing AC cells at 1?week (OR=2.5, p>0.00001) and at 2 weeks (OR=2.5, p=0.04), as well as clearing the AC flare at 2 weeks (OR=6.7, p=0.04). After phacoemulsification, difluprednate was superior in terms of corneal clarity at 1?day (OR=2.6, p=0.02) and 1?week after surgery (OR=1.96, p=0.0007). No statistically significant difference was detected between both agents at 1?month in effectiveness. Also, both agents were safe, evaluated by the ocular hypertension (OR=1.23, p=0.8). CONCLUSION:With low-to-moderate certainty, difluprednate and prednisolone acetate are safe agents for controlling the inflammation after cataract surgery. Difluprednate showed significant superiority in terms of AC cells and AC flare at 2 weeks postoperatively.

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 determine whether intraoperative aberrometry during cataract surgery measures higher levels of absolute astigmatism than preoperative biometry readings and which method yields a lower, final level of astigmatism if the two do not agree.Patients and methodsRetrospective record review of all patients who underwent uncomplicated cataract surgery from February 2015 to May 2019 with planned intraoperative aberrometry. Data analysis included preoperative keratometry, total astigmatism as measured by intraoperative aberrometry, intraocular lens model and power used, and postoperative manifest refraction ≥1 month after surgery. The primary outcome measure was the proportion of patients requiring astigmatism correction (≥0.5 D) when measured by preoperative keratometry vs intraoperative aberrometry. Secondary outcomes included postoperative residual astigmatism, where adjusted preoperative astigmatism fell below the 0.5 D threshold for treatment but the intraoperative measurement was ≥0.5 D or ≥1.0 D.ResultsA total of 451 patient records were evaluated. Intraoperative aberrometry measured statistically higher levels of mean astigmatism than keratometry (0.86 D vs 0.79 D, respectively; P < 0.0001) and significantly greater astigmatism among patients with 0.5-1.5 D of adjusted preoperative astigmatism (P < 0.0001). Significantly more patients qualified for with-the-rule astigmatism correction when measured by intraoperative aberrometry (n=339; 75%) than by preoperative keratometry alone (n=314; 70%); P < 0.03. This difference did not hold for against-the-rule or oblique astigmatism. For patients whose preoperative biometry astigmatism differed from intraoperative biometry, final postoperative astigmatism was lower when corrected if the adjusted preoperative and intraoperative measurements had a vector difference of <0.5 D, but there was no additional benefit in final astigmatism reduction when the vector difference was ≥0.5 D.ConclusionUsing intraoperative biometry readings can produce lower postoperative astigmatism than using preoperative biometry readings, but caution should be used when interpreting intraoperative readings that disagree with preoperative measurements with a vector magnitude of >0.5 D.

Dataset Information

Effect of preoperative use of topical prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery: a randomized trial.

Publications

Effect of preoperative use of topical prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery: a randomized trial.

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