- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01480557
Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Evros
-
Alexandroupolis, Evros, Greece, 68100
- University Hospital of Alexandroupolis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Georgios Labiris, MD, PhD, Democritus University of Thrace
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- liq75tor
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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