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

Sponsor

Democritus University of Thrace (Other)

Overall Status

Completed

CT.gov ID

NCT02304861

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Viscoat Procedure: Visthesia	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Endothelial Cell Count (ECD) [3 months postoperatively]

Secondary Outcome Measures

Endothelial Cell pattern (ECP) [3 months postoperatively]
Central corneal edema (CCE) [3 months postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Alexandroupolis	Alexandroupolis	Evros	Greece	68100

Sponsors and Collaborators

Democritus University of Thrace

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgios Labiris, Assistant Professor, Democritus University of Thrace

ClinicalTrials.gov Identifier:

NCT02304861

Other Study ID Numbers:

visco07012eit

First Posted:

Dec 2, 2014

Last Update Posted:

Jan 18, 2017

Last Verified:

Jan 1, 2017

Keywords provided by Georgios Labiris, Assistant Professor, Democritus University of Thrace

cataract

viscoelastic (OVD) technology

endothelial cell count

endothelial cell pattern

central corneal edema

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Jan 18, 2017