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

January 14, 2017 updated by: Georgios Labiris, Democritus University of Thrace

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • University Hospital of Alexandroupolis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Liquefaction group
Subjects that were operated for cataract using liquefaction technology
Cataract extraction surgery type
Active Comparator: Torsional ip group
Subjects that were operated for cataract using torsional ip technology
A type cataract surgery using torsional ip technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial cell count (ECC)
Time Frame: 1 month postoperatively
1 month postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Uncorrected visual acuity (UVA)
Time Frame: 1 month postoperatively
1 month postoperatively
Central corneal thickness (CCT)
Time Frame: 1 month postoperatively
1 month postoperatively
Central Corneal Sensitivity (CCS)
Time Frame: 1 month postoperatively
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Georgios Labiris, MD, PhD, Democritus University of Thrace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 14, 2017

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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