Abstract
Purpose :
To apply a complications classification to the DRCR Retina Network Protocol AB study.
Methods :
The Classification of Ophthalmological Complications (COC) was derived from the Clavien-Dindo classification used in multiple surgical specialties. Complications are graded based on the degree of invasiveness required to correct it, and a complication is defined as any deviation from the normal postoperative course. All adverse events compiled in the Protocol AB study were then reviewed and attributed a grade ranging from I to VII. Comparisons were made between both treatment groups (i.e., prompt vitrectomy + panretinal photocoagulation (PRP), and intravitreal anti-vascular endothelial growth factor (anti-VEGF)).
Results :
There were 2213 reported adverse events. Among these, 1038 were classified as grade I complications (i.e., no change in treatment or routine drops, artificial tears, analgesics like acetaminophen or nonsteroidal anti-inflammatory drugs only), 586 as grade II (i.e., longer duration or higher frequency drops, oral drugs other than acetaminophen or nonsteroidal anti-inflammatory drugs), 46 as grade III (i.e., laser procedures, injections, simple interventions not requiring an operating room (OR) setup), 442 as grade IV (i.e., requiring reintervention in the OR, intravenous drugs, hospitalization), 3 as grade V (i.e., sight-threatening complications like endophthalmitis), 23 as grade VI (i.e., life-threatening complications requiring an intensive care unit management), and 10 as grade VII (i.e., death).
There was a greater median [Q1, Q3] number of grade I complications and grade II complications in patients treated using anti-VEGF compared to patients treated with prompt vitrectomy + PRP (grade I: 4.5 [2.0, 7.8] vs. 3.0 [1.0, 5.0]; p=0.004 and grade II: 3.0 [1.0, 5.0] vs. 2.0 [0.0, 4.0]; p=0.001). Higher grade complications did not differ by treatment group. Comparing the highest complication grade for a given patient, the anti-VEGF group had a median [Q1, Q3] grade of 4 [4, 4], while the prompt vitrectomy + PRP group had a median [Q1, Q3] grade of 4 [2, 4] (p=0.044).
Conclusions :
The COC may be an interesting method to quantify morbidity in ophthalmology. The increased number of low-grade complications in the anti-VEGF group may be attributable to the higher number of procedures performed and the more frequent follow-ups where patients could more readily report adverse events.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.