Comparison of Post-Operative Outcomes between IOP-20 and IOP-50 in Phacoemulsification with Active Fluidics System: Randomized Single Blinded Trial
Abstract
Purpose: To compare the central corneal thickness, mitigation events, post-operative vision, and complications in patients who underwent cataract surgery using the CENTURION ® Vision System with the ACTIVE SENTRY ® (Alcon Industries, Inc.) system and were assigned to one of two groups: intraocular pressure (IOP) group 20 or 50.
Setting: Wavikar Eye Institute, Thane, India.
Design: A prospective comparative two arm, randomized, single blinded, interventional study.
Methods: A total of 107 eyes were randomized to either the IOP-20 (n=55) or IOP-50 (n=52) group. All patients underwent phacoemulsification with an active fluidics system performed by a single surgeon; intraocular pressure (IOP) was set at either 20 or 50 mmHg.
Results: The mean [SD] baseline CCT in the IOP-20 group was 511.9 [35.7] μm and it was 521.1 [34.8] μm in the IOP 50 group (p=0.18). It had changed to 530.6 [39.8] μm in the IOP-20 group and 539.5 [39.2] μm in the IOP 50 (p=0.24). The mean [SD] ECD at the end of day 90 was 2423.0 [204.6] cells/mm2 in the IOP-20 group and 2476.1 [236.0] cells/mm2 in the IOP-50 group (p=0.22). Approximately 22% of the eyes in the IOP-20 group and 77% of the eyes in the IOP-50 group required active surge mitigation; this difference was statistically significant (p<0.001).
Conclusion: We found that the phacoemulsification with an active fluidics system handpiece at 20 mmHg provided a safe and stable environment for cataract surgery.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 55 participants or records.
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