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Is a combination of corticosteroid and nonsteroidal anti-inflammatory drug (NSAID) eye drops superior to NSAID eye drops alone or dropless surgery with a sub-Tenon dexamethasone depot in controlling postoperative central macular thickening after uncomplicated cataract surgery?
In this randomized clinical trial with 470 participants, no differences in central subfield thickness or visual acuity across treatment arms were identified, although approximately half of the group given the sub-Tenon depot received additional anti-inflammatory treatment.
Therapy with NSAID plus corticosteroid eye drops was not superior to NSAID monotherapy or sub-Tenon depot for postoperative central macular thickening after uncomplicated cataract surgery.
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.
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.
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.
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) 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 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 NSAIDs may be preferred in uncomplicated cataract surgery.
ClinicalTrials.gov Identifier: NCT03383328
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Accepted for Publication: June 23, 2021.
Published Online: August 12, 2021. doi:10.1001/jamaophthalmol.2021.2976
Correction: This article was corrected on October 21, 2021, to correct a typographical error in the title of the Visual Abstract.
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Erichsen JH et al. JAMA Ophthalmology.
Corresponding Author: Jesper Høiberg Erichsen, MD, PhD, Department of Ophthalmology, Rigshospitalet Glostrup, Valdemar Hansens Vej 1-23, 2600 Glostrup, Denmark (firstname.lastname@example.org).
Author Contributions: Drs Erichsen and Kessel had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Erichsen, Holm, Kessel.
Acquisition, analysis, or interpretation of data: Erichsen, Forslund Jacobsen, Forman, Kessel.
Drafting of the manuscript: Erichsen, Holm.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Erichsen, Forman.
Obtained funding: Erichsen, Kessel.
Administrative, technical, or material support: Erichsen, Holm, Forslund Jacobsen, Kessel.
Supervision: Holm, Forman, Kessel.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was supported by grant DFF–7016-00161 from Independent Research Fund Denmark (Dr Erichsen), by Fight for Sight Denmark (Dr Erichsen), and by the Henry og Astrid Møllers Fond (Dr Erichsen).
Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 4.
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