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

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ClinicalTrials.gov Identifier: NCT02304861
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. Endothelial Cell Count (ECD) [ Time Frame: 3 months postoperatively ]

Secondary Outcome Measures :
  1. Endothelial Cell pattern (ECP) [ Time Frame: 3 months postoperatively ]
  2. Central corneal edema (CCE) [ Time Frame: 3 months postoperatively ]


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304861


Locations
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Greece
University Hospital of Alexandroupolis
Alexandroupolis, Evros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
Investigators
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Principal Investigator: Georgios Labiris, MD, PhD Democritus University of Thrace

Publications of Results:
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Responsible Party: Georgios Labiris, Assistant Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT02304861     History of Changes
Other Study ID Numbers: visco07012eit
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Georgios Labiris, Democritus University of Thrace:
cataract
viscoelastic (OVD) technology
endothelial cell count
endothelial cell pattern
central corneal edema

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Phenylephrine
Oxymetazoline
Lidocaine
Hyaluronic Acid
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents