Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

Cataract Clinical Trial

Official title:

Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480557
• Other study ID #: liq75tor
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: January 14, 2017
• Start date: April 2011
• Est. completion date: November 2011

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 impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients.

Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale [10]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

Inclusion Criteria:

• Diagnosis of senile cataract with stage 2 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
• Corneal Edema
• Hypersensitivity

Intervention

Procedure:
• liquefaction
Cataract extraction surgery type
• Torsional ip
A type cataract surgery using torsional ip technology

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, Gatzioufas Z, Giarmoukakis A, Sideroudi H, Kozobolis VP. Liquefaction versus torsional IP: a comparative study on endothelial cells, corneal edema and corneal sensitivity. Ophthalmic Res. 2013;49(1):37-42. doi: 10.1159/000342974. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial cell count (ECC)		1 month postoperatively
Secondary	Uncorrected visual acuity (UVA)		1 month postoperatively
Secondary	Central corneal thickness (CCT)		1 month postoperatively
Secondary	Central Corneal Sensitivity (CCS)		1 month postoperatively