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

NCT02304861 | Completed DMC

• 1 other identifier: visco07012eit
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cataract

Keywords

cataract; viscoelastic (OVD) technology; endothelial cell count; endothelial cell pattern; central corneal edema

Outcome Measures

Primary Outcomes (1)

• Endothelial Cell Count (ECD)

  3 months postoperatively

Secondary Outcomes (2)

• Endothelial Cell pattern (ECP)

  3 months postoperatively

• Central corneal edema (CCE)

  3 months postoperatively

Study Arms (2)

Viscoat group

ACTIVE COMPARATOR

Patients operated using Viscoat OVD

Procedure: Viscoat

Visthesia group

ACTIVE COMPARATOR

Patients operated using Visthesia OVD

Procedure: Visthesia

Interventions

Viscoat PROCEDURE

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

Viscoat group

Visthesia PROCEDURE

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

Visthesia group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (1)

• 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.

  PMID: 25804586 RESULT

MeSH Terms

Conditions

Cataract

Interventions

chondroitin sulfate, sodium hyaluronate drug combination; visthesia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Georgios Labiris, MD, PhD

  Democritus University of Thrace

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

GR (1)