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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT01480557
First received: November 22, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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).


Condition Intervention
Cataract
Procedure: liquefaction
Procedure: Torsional ip

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

Resource links provided by NLM:


Further study details as provided by Democritus University of Thrace:

Primary Outcome Measures:
  • Endothelial cell count (ECC) [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uncorrected visual acuity (UVA) [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]
  • Central corneal thickness (CCT) [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]
  • Central Corneal Sensitivity (CCS) [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: April 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liquefaction group
Subjects that were operated for cataract using liquefaction technology
Procedure: liquefaction
Cataract extraction surgery type
Active Comparator: Torsional ip group
Subjects that were operated for cataract using torsional ip technology
Procedure: Torsional ip
A type cataract surgery using torsional ip technology

  Eligibility

Ages Eligible for Study:   55 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480557

Locations
Greece
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
  More Information

No publications provided by Democritus University of Thrace

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Georgios Labiris, Senior Lecturer, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT01480557     History of Changes
Other Study ID Numbers: liq75tor
Study First Received: November 22, 2011
Last Updated: November 28, 2011
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Democritus University of Thrace:
cataract
phacoemulsification
liquefaction
torsional ip
endothelial cell count
central corneal edema
central corneal sensitivity

Additional relevant MeSH terms:
Cataract
Corneal Edema
Lens Diseases
Eye Diseases
Corneal Diseases

ClinicalTrials.gov processed this record on October 01, 2014