Large randomized trial compares efficacy and safety of multiple regimens
This article was reviewed by Jesper Høiberg Erichsen, MD
Results of a prospective randomized trial comparing 5 medication regimens for controlling inflammation early after uncomplicated surgery show that beginning monotherapy with a topical nonsteroidal anti-inflammatory drug (NSAID) the day of surgery offered the best outcome for efficacy and safety.
The findings, presented by Jesper Høiberg Erichsen, MD, revealed that adding a topical steroid to the NSAID provided no benefit but could adversely affect intraocular pressure.
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Initiating topical treatment 3 days preoperatively also conferred no advantage for better inflammation control, whereas a dropless approach using a sub-Tenon corticosteroid injection proved inferior to topical treatment.
“Controlling postoperative inflammation is important for achieving a successful outcome after cataract surgery. Surgeons generally prescribe an anti-inflammatory prophylactic regimen parallel to surgery, and recent meta-analyses have documented a beneficial effect of using a topical NSAID,” said Erichsen, a doctoral student in the Department of Ophthalmology at Rigshospitalet-Glostrup in Denmark.
He added that several questions about inflammation prophylaxis require investigation.
“Based on our results, we recommend that cataract surgeons consider using NSAID monotherapy as anti-inflammatory prophylaxis in uncomplicated cases,” he said.
Patients with a senile cataract were eligible for enrollment in the study if they were undergoing uncomplicated surgery and had no history of diabetes, uveitis, glaucoma, retinal vein occlusion, epiretinal membrane, retinal detachment, or advanced age-related macular degeneration.
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A total of 470 patients were randomly selected in 5 equal groups to receive topical prednisolone and ketorolac started 3 days preoperatively, topical prednisolone and ketorolac started on the day of surgery, ketorolac started 3 days preoperatively, ketorolac started on the day of surgery, or a sub-Tenon depot of dexamethasone 2 mg/0.5 mL.
All topical drops were to be administered 3 times daily and continued for 21 days after surgery.
After random selection, 14 patients were excluded, and 438 completed follow-up to the primary end point visit at postoperative day 3. The mean age of the 456 patients included in the baseline data analysis was 72 years, and almost two-thirds of the participants were women.
The primary outcome assessed change from baseline in anterior chamber flare measured on undilated pupils using a flare photometer (Kowa FM-600, Kowa Company).
For statistical analyses, the group that received the combination topical regimen started preoperatively was used as the control group.
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Median flare was 10.1 photon counts per millisecond at baseline in all groups, and it increased significantly at postop day 3 in all groups.
The greatest rise occurred in the dropless group, and the difference in change from baseline compared with the control group was statistically significant only in the dropless group.
“As another interesting result, we found that only a few patients in the topical treatment groups [1.1%-3.4%] needed additional intervention to control inflammation, whereas more than one-third of patients in the dropless group needed rescue anti-inflammatory treatment,” Erichsen said. “Minimizing the need for topical drops is desirable in older patients who may struggle with administration, but the dropless approach using the sub-Tenon injection did not seem effective for achieving that goal.”
Anterior chamber cell count at postop day 3 was investigated as a secondary outcome measure. The mean value was 3.4 in the control group, ranged from 3.8 to 4.1 in the 3 other topical regimen groups, and was 5.5 in the dropless group.
Again, Erichsen noted that the only the difference between the dropless and control groups was statistically significant.
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Postop day 3 logMAR visual acuity measured with Early Treatment Diabetic Retinopathy Study charts was also evaluated as a secondary end point.
The results showed no significant differences between groups.
Intraocular pressure, another secondary outcome measure, was found to decrease significantly after cataract surgery in all groups.
However, the drop was significantly less in the combination treatment groups that received a topical steroid compared with those receiving a topical NSAID alone and the dropless group.
Erichsen initially made his presentation at the virtual Association for Research in Vision and Ophthalmology 2020 annual meeting.
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Jesper Høiberg Erichsen, MD
Neither Erichsen nor any of his coauthors has any relevant financial interests to disclose.