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

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).

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: Viscoat; Procedure: Visthesia

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupolis, Evros, Greece, 68100
      • University Hospital of Alexandroupolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Viscoat group; Patients operated using Viscoat OVD	Procedure: Viscoat; Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision 3% Sodium Hyaluronate, 4% Chondroitin Sulfate (Viscoat, Alcon, Greece) was injected in the anterior chamber
Active Comparator: Visthesia group; Patients operated using Visthesia OVD	Procedure: Visthesia; Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision sodium hyaluronate 1.5% and lidocaine hydrochloride 1% ophthalmic viscosurgical device (OVD) (Visthesia, Carl Zeiss, Germany) was injected in the anterior chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endothelial Cell Count (ECD)	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Endothelial Cell pattern (ECP)	3 months postoperatively
Central corneal edema (CCE)	3 months postoperatively

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Principal Investigator: Georgios Labiris, MD, PhD, Democritus University of Thrace

Publications and helpful links

General Publications

• Labiris G, Sideroudi H, Rousopoulos K, Kozobolis VP. Cohesive versus dispersive-cohesive ophthalmic viscosurgical device in torsional intelligent phaco. J Cataract Refract Surg. 2015 Mar;41(3):681-2. doi: 10.1016/j.jcrs.2015.01.010. No abstract available.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 11, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 14, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: cataract; viscoelastic (OVD) technology; endothelial cell count; endothelial cell pattern; central corneal edema
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: visco07012eit