ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01480557
Recruitment Status : Completed
First Posted : November 29, 2011
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 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 or disease Intervention/treatment Phase
Cataract Procedure: liquefaction Procedure: Torsional ip Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
Study Start Date : April 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Cataract Edema

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Endothelial cell count (ECC) [ Time Frame: 1 month postoperatively ]

Secondary Outcome Measures :
  1. Uncorrected visual acuity (UVA) [ Time Frame: 1 month postoperatively ]
  2. Central corneal thickness (CCT) [ Time Frame: 1 month postoperatively ]
  3. Central Corneal Sensitivity (CCS) [ Time Frame: 1 month postoperatively ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): 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

Publications of Results:
Responsible Party: Georgios Labiris, Senior Lecturer, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT01480557     History of Changes
Other Study ID Numbers: liq75tor
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Hypersensitivity
Cataract
Corneal Edema
Immune System Diseases
Lens Diseases
Eye Diseases
Corneal Diseases