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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304861
• Other study ID #: visco07012eit
• Status: Completed
• Phase: N/A
• First received: November 11, 2014
• Last updated: January 14, 2017
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2017
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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
• 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

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Cell Count (ECD)		3 months postoperatively
Secondary	Endothelial Cell pattern (ECP)		3 months postoperatively
Secondary	Central corneal edema (CCE)		3 months postoperatively