- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02304861
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Evros
-
Alexandroupolis, Evros, Greece, 68100
- University Hospital of Alexandroupolis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Viscoat group
Patients operated using Viscoat OVD
|
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
|
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)
Time Frame: 3 months postoperatively
|
3 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelial Cell pattern (ECP)
Time Frame: 3 months postoperatively
|
3 months postoperatively
|
Central corneal edema (CCE)
Time Frame: 3 months postoperatively
|
3 months postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Georgios Labiris, MD, PhD, Democritus University of Thrace
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- visco07012eit
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