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Clinical evaluation of endothelial cell decrease with VisThesia in phacoemulsification surgery.
Francisco Poyales-Galan1, Giovanni Pirazzoli
1Instituto de Oftalmologia Avanzada, Madrid, Spain. fpoyales@oftalmologia-avanzada.com
Journal of Cataract and Refractive Surgery
|January 18, 2006
Summary
The ophthalmic viscosurgical device VisThesia, containing sodium hyaluronate and lidocaine, showed no increased corneal toxicity or endothelial cell loss compared to similar devices. This study assessed its safety and efficacy in cataract surgery patients.
Area of Science:
- Ophthalmology
- Corneal Science
- Surgical Innovation
Background:
- Ophthalmic viscosurgical devices (OVDs) are crucial in ophthalmic surgery, particularly phacoemulsification.
- Patient comfort during surgery under topical anesthesia is a significant consideration.
- Sodium hyaluronate-based OVDs are commonly used, but the addition of anesthetics warrants safety evaluation.
Purpose of the Study:
- To evaluate endothelial cell decrease following the use of sodium hyaluronate 0.3% and lidocaine hydrochloride 2% (VisThesia).
- To determine if lidocaine 1% added to sodium hyaluronate 1.5% increases corneal toxicity.
- To compare the safety profile of VisThesia with other OVDs.
Main Methods:
- A prospective study involving 50 eyes of 50 patients undergoing phacoemulsification.
- Application of VisThesia Topical followed by intracameral use as the routine OVD.
- Noncontact specular microscopy to assess central corneal endothelium preoperatively and at 3 months post-surgery.
Main Results:
- Mean best corrected visual acuity was 0.88 +/- 0.18, and mean manifest spherical equivalent was -0.36 +/- 1.78 D at 3 months.
- Mean endothelial cell density decreased from 2363.57 +/- 435.4 cells/mm² preoperatively to 2222.6 +/- 537.69 cells/mm² at 3 months.
- Observed endothelial cell loss is comparable to that reported for other OVDs in the literature.
Conclusions:
- The addition of lidocaine to sodium hyaluronate in VisThesia does not induce additional toxicity.
- VisThesia does not result in increased endothelial cell loss compared to similar ophthalmic viscosurgical devices.
- The findings support the safety of VisThesia for use in cataract surgery.