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
1 other identifier
interventional
75
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedJanuary 18, 2017
January 1, 2017
5 months
November 22, 2011
January 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial cell count (ECC)
1 month postoperatively
Secondary Outcomes (3)
Uncorrected visual acuity (UVA)
1 month postoperatively
Central corneal thickness (CCT)
1 month postoperatively
Central Corneal Sensitivity (CCS)
1 month postoperatively
Study Arms (2)
Liquefaction group
ACTIVE COMPARATORSubjects that were operated for cataract using liquefaction technology
Torsional ip group
ACTIVE COMPARATORSubjects that were operated for cataract using torsional ip technology
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
You may not qualify if:
- Endothelial cell count less than 1900,
- glaucoma,
- IOP-lowering medications,
- former incisional surgery,
- former diagnosis of corneal disease,
- diabetes or autoimmune diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100, Greece
Related 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. Epub 2012 Oct 23.
PMID: 23095606RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgios Labiris, MD, PhD
Democritus University of Thrace
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
November 22, 2011
First Posted
November 29, 2011
Study Start
April 1, 2011
Primary Completion
September 1, 2011
Study Completion
November 1, 2011
Last Updated
January 18, 2017
Record last verified: 2017-01