Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss

Democritus University of Thrace

Status: Completed

Conditions: Cataract

Treatments: Procedure: Viscoat; Procedure: Visthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02304861

visco07012eit

Details and patient eligibility

About

Objective of this study is the comparative assessment of the beneficial impact of the Viscoat viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema following torsional-ip cataract extraction surgery.

Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale. By means of a custom computer randomization program all participants will randomly populate two study groups according to the OVD used (ie. viscoat or visthesia).

Enrollment: 80 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of senile cataract with stage 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion criteria

• Endothelial cell count less than 1900,
• glaucoma,
• IOP-lowering medications,
• former incisional surgery,
• former diagnosis of corneal disease,
• diabetes or autoimmune diseases

Trial design

80 participants in 2 patient groups

Viscoat group

Active Comparator group

Description:

Patients operated using Viscoat OVD

Treatment:

Procedure: Viscoat

Visthesia group

Active Comparator group

Description:

Patients operated using Visthesia OVD

Treatment:

Procedure: Visthesia