Prednisolone combined with a non-steroidal anti-inflammatory drug (NSAID) did not prevent the thickening of the central subfield after cataract surgery any better than using NSAID drops alone, and initiating prophylactic treatment 3 days before surgery was not superior to initiating treatment the day of surgery, according to a report. The analysis published in JAMA Ophthalmology scrutinizes the effectiveness of several anti-inflammatory regimens, including combination prednisolone – NSAID drops, NSAID monotherapy, and sub-Tenon depot injection, or “dropless” cataract surgery.
Low-risk patients with upcoming cataract surgery (N=470) were recruited at the Department of Ophthalmology, Rigshospitalet Glostrup, in Glostrup, Denmark between February 2018 and August 2019. The investigation randomized participants equally into 1 of 5 cohorts. Treatment protocols included the following:
- Control group: 3-day preoperative start of combination eye drops: prednisolone 1% and the NSAID ketorolac tromethamine 0.5%.
- Postoperative-initiated (day of surgery) combination drops with prednisolone and NSAID.
- Preoperative NSAID monotherapy.
- Postoperative NSAID monotherapy.
- Sub-Tenon depot injection at surgery conclusion with dexamethasone phosphate.
A “computerized coin toss” selected 1 eye of each participant for data collection. Intergroup results for mean central subfield thickness (CST) 3 months after phacoemulsification were similar; 250.7 μm for preoperative combination drop control patients, 250.7 μm in postoperative combination drop therapy individuals, 251.3 μm for preoperative NSAID monotherapy participants, 249.2 μm in postoperative NSAID monotherapy group members, and 255.2 μm for those in the sub-Tenon or “dropless” group.
No significant difference was found between the control and postoperative combination eyedrop groups (P =.97), or between the control and preoperative NSAID cohorts (P =.79), or control and postoperative NSAID groups (P =.51). The only significant difference occurred between the control and sub-Tenon patients (P =.04). Also, no important 3-month differences between sets were noted for intraocular pressure (IOP) or corrected distance visual acuity. Subjective discomfort also did not meaningfully vary at 3-day and 3-week follow-ups. Further, there were no differences when comparing pre- or post-op start of therapies for CST, IOP, or visual acuity.
Adverse events, or the indication for additional anti-inflammatory medications were recorded. No differences were found between control and comparison sets, except that additional anti-inflammatory drops were needed for 56.6% of patients in the sub-Tenon cohort. There were also approximately twice as many clinic visits for those who underwent sub-Tenon depot.
The mean age of participants was 72.2 years, and all received hydrophobic intraocular lenses (IOLs). Fourteen were excluded from the data due to surgical complications or other factors. Compliance data was not tracked for instilling eye drops. Of the total, 429 completed the final follow-up. A limitation of the study was exclusion of patients with risk factors such as diabetes. Also, it did not include a corticosteroid monotherapy group. This investigation’s strength was its power to reveal a difference of even 5 μm in CST.
NSAID monotherapy is still debated in the US, although some prior studies and the current paper have demonstrated its potential effectiveness, the research added. The analysis speculates that “NSAID monotherapy with initiation on the day of surgery may be preferred as an anti-inflammatory prophylactic regimen in uncomplicated cataract surgery.”
Erichsen JH, Holm LM, Jacobsen MF, et al. Prednisolone and ketorolac vs ketorolac monotherapy of sub-tenon prophylaxis for macular thickening in cataract surgery. JAMA Ophthalmol. Published online August 12, 2021. doi:10.1001/jamaophthalmol.2021.2976