CataractNCT01480557
Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
A study testing liquefaction and Torsional ip in people with Cataract, run by Democritus University of Thrace at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Cataract
- What is being tested?
- liquefaction and Torsional ip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
Who cannot join
- Endothelial cell count less than 1900,
- glaucoma,
- IOP-lowering medications,
- former incisional surgery,
- former diagnosis of corneal disease,
- diabetes or autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: 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).
- Conditions
- Cataract
- Being tested
- liquefaction, Torsional ip
- Keywords
- cataract, phacoemulsification, liquefaction, torsional ip, endothelial cell count, central corneal edema, central corneal sensitivity
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquefactionProcedure or surgery
Cataract extraction surgery type
Torsional ipProcedure or surgery
A type cataract surgery using torsional ip technology
| Study group | Role | What they receive |
|---|---|---|
| Liquefaction group | Active comparator | Subjects that were operated for cataract using liquefaction technology Receives: Procedure: liquefaction |
| Torsional ip group | Active comparator | Subjects that were operated for cataract using torsional ip technology Receives: Procedure: Torsional ip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell count (ECC)
Measured: 1 month postoperatively
Secondary outcomes (3)
Uncorrected visual acuity (UVA)
Measured: 1 month postoperatively
Central corneal thickness (CCT)
Measured: 1 month postoperatively
Central Corneal Sensitivity (CCS)
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Principal investigator, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480557
- Sponsor's protocol ID
- liq75tor
- Status last verified
- Jan 2017
- First submitted
- 22 Nov 2011
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23095606
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
- ClinicalTrials.gov ID
- NCT01480557
- Acronym / sponsor ID
- liq75tor
- Conditions
- Cataract
- Keywords
- cataract, phacoemulsification, liquefaction, torsional ip, endothelial cell count, central corneal edema, central corneal sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquefaction group | Active comparator | Procedure: liquefactionSubjects that were operated for cataract using liquefaction technology |
| Torsional ip group | Active comparator | Procedure: Torsional ipSubjects that were operated for cataract using torsional ip technology |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
Key exclusion criteria (6 listed)
- Endothelial cell count less than 1900,
- glaucoma,
- IOP-lowering medications,
- former incisional surgery,
- former diagnosis of corneal disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liquefactionCataract extraction surgery type | Procedure or surgery | Liquefaction group |
| Torsional ipA type cataract surgery using torsional ip technology | Procedure or surgery | Torsional ip group |
Primary outcome
Endothelial cell count (ECC)
Time frame: 1 month postoperatively
3 secondary outcomes
Uncorrected visual acuity (UVA)
Time frame: 1 month postoperatively
Central corneal thickness (CCT)
Time frame: 1 month postoperatively
Central Corneal Sensitivity (CCS)
Time frame: 1 month postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Results publication: PubMed 23095606Labiris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Labiris, MD, PhD principal investigator
Democritus University of Thrace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liquefaction and Torsional ip in people with Cataract, run by Democritus University of Thrace at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell count (ECC) (time frame: 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.