Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial

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Standard

Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery : A Randomized Clinical Trial. / Erichsen, Jesper Hoiberg; Holm, Lars M.; Jacobsen, Mads Forslund; Forman, Julie L.; Kessel, Line.

I: JAMA Ophthalmology, Bind 139, Nr. 10, 2021, s. 1062-1070.

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Harvard

Erichsen, JH, Holm, LM, Jacobsen, MF, Forman, JL & Kessel, L 2021, 'Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial', JAMA Ophthalmology, bind 139, nr. 10, s. 1062-1070. https://doi.org/10.1001/jamaophthalmol.2021.2976

APA

Erichsen, J. H., Holm, L. M., Jacobsen, M. F., Forman, J. L., & Kessel, L. (2021). Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial. JAMA Ophthalmology, 139(10), 1062-1070. https://doi.org/10.1001/jamaophthalmol.2021.2976

Vancouver

Erichsen JH, Holm LM, Jacobsen MF, Forman JL, Kessel L. Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial. JAMA Ophthalmology. 2021;139(10):1062-1070. https://doi.org/10.1001/jamaophthalmol.2021.2976

Author

Erichsen, Jesper Hoiberg ; Holm, Lars M. ; Jacobsen, Mads Forslund ; Forman, Julie L. ; Kessel, Line. / Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery : A Randomized Clinical Trial. I: JAMA Ophthalmology. 2021 ; Bind 139, Nr. 10. s. 1062-1070.

Bibtex

@article{7496a21ac5d44f01a88fffc01151100a,
title = "Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial",
abstract = "IMPORTANCE The 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.OBJECTIVES To 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 PARTICIPANTS This 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.INTERVENTIONS Participants 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 MEASURES CST 3 months postoperatively. RESULTS A 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) mu min the preoperative prednisolone plus NSAID group, 250.7 (95% CI, 247.8-253.7) mu min the postoperative prednisolone plus NSAID group, 251.3 (95% CI, 248.2-254.4) mu min the preoperative NSAID group, 249.2 (95% CI, 246.2-252.3) mu m in the postoperative NSAID group, and 255.2 (95% CI, 252.0-258.3) mu m 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 RELEVANCE No 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 NSAIDsmay be preferred in uncomplicated cataract surgery.",
keywords = "EUROPEAN MULTICENTER TRIAL, EDEMA, PREVENTION, INFLAMMATION, MANAGEMENT, SYSTEM",
author = "Erichsen, {Jesper Hoiberg} and Holm, {Lars M.} and Jacobsen, {Mads Forslund} and Forman, {Julie L.} and Line Kessel",
year = "2021",
doi = "10.1001/jamaophthalmol.2021.2976",
language = "English",
volume = "139",
pages = "1062--1070",
journal = "JAMA Ophthalmology",
issn = "2168-6165",
publisher = "The JAMA Network",
number = "10",

}

RIS

TY - JOUR

T1 - Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery

T2 - A Randomized Clinical Trial

AU - Erichsen, Jesper Hoiberg

AU - Holm, Lars M.

AU - Jacobsen, Mads Forslund

AU - Forman, Julie L.

AU - Kessel, Line

PY - 2021

Y1 - 2021

N2 - IMPORTANCE The 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.OBJECTIVES To 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 PARTICIPANTS This 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.INTERVENTIONS Participants 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 MEASURES CST 3 months postoperatively. RESULTS A 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) mu min the preoperative prednisolone plus NSAID group, 250.7 (95% CI, 247.8-253.7) mu min the postoperative prednisolone plus NSAID group, 251.3 (95% CI, 248.2-254.4) mu min the preoperative NSAID group, 249.2 (95% CI, 246.2-252.3) mu m in the postoperative NSAID group, and 255.2 (95% CI, 252.0-258.3) mu m 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 RELEVANCE No 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 NSAIDsmay be preferred in uncomplicated cataract surgery.

AB - IMPORTANCE The 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.OBJECTIVES To 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 PARTICIPANTS This 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.INTERVENTIONS Participants 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 MEASURES CST 3 months postoperatively. RESULTS A 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) mu min the preoperative prednisolone plus NSAID group, 250.7 (95% CI, 247.8-253.7) mu min the postoperative prednisolone plus NSAID group, 251.3 (95% CI, 248.2-254.4) mu min the preoperative NSAID group, 249.2 (95% CI, 246.2-252.3) mu m in the postoperative NSAID group, and 255.2 (95% CI, 252.0-258.3) mu m 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 RELEVANCE No 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 NSAIDsmay be preferred in uncomplicated cataract surgery.

KW - EUROPEAN MULTICENTER TRIAL

KW - EDEMA

KW - PREVENTION

KW - INFLAMMATION

KW - MANAGEMENT

KW - SYSTEM

U2 - 10.1001/jamaophthalmol.2021.2976

DO - 10.1001/jamaophthalmol.2021.2976

M3 - Journal article

C2 - 34383010

VL - 139

SP - 1062

EP - 1070

JO - JAMA Ophthalmology

JF - JAMA Ophthalmology

SN - 2168-6165

IS - 10

ER -

ID: 276846085