CataractPhase 4NCT01010490
Outcomes of Phacoemulsification With Torsional Ultrasound
A Phase 4 study testing Torsional ultrasound (INFINITI, Alcon, USA), Longitudinal U/S (Infiniti system, Alcon, USA) and Longitudinal U/S (LEGACY 20000, Alcon, USA) in people with Cataract, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
To determine the differences in intra-operative complications, surgical duration, fluid usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery and at post-operative day 1, 1 month and 3 months. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Torsional ultrasound (INFINITI, Alcon, USA), Longitudinal U/S (Infiniti system, Alcon, USA) and Longitudinal U/S (LEGACY 20000, Alcon, USA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteIndia
- Study dates
- May 2007to Mar 2009
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients 55 years and older with a senile cataract grades 1 to 5 nuclear sclerosis based on Emery's classification,
- endothelial cell density > 1500 cells/mm2,
- anterior chamber depth > 2.4 mm, and
- a dilated pupil > 7 mm.
Who cannot join
- eyes with pseudoexfoliation,
- mature, traumatic, or complicated cataracts,
- history of previous intra-ocular surgery, glaucoma, uveitis, and
- patients who were unable to comply with follow-up examinations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Trial of Torsional Ultrasound Versus Longitudinal Ultrasound During Phacoemulsification of Age-related Cataracts: Comparison of Intra-operative Performance and Impact on Post-operative Endothelium Integrity
To determine the differences in intra-operative complications, surgical duration, fluid usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery and at post-operative day 1, 1 month and 3 months.
Read the detailed description
Introduced in mid 2006, torsional ultrasound (OZil, Infiniti Vision System, Alcon Laboratories, Texas, USA) uses rotational oscillations at ultrasonic frequencies to emulsify cataractous lens material in a seamless cutting motion from a tip that oscillates laterally. The side-to-side movement of the phaco tip produces minimal repulsion of lens material from the phaco tip resulting in improved followability. Clinically this translates into more effective lens removal with torsional phaco in comparison to the conventional ultrasound mode.to test this in a clinical scenario we undertook this study.
- Conditions
- Cataract
- Being tested
- Torsional ultrasound (INFINITI, Alcon, USA), Longitudinal U/S (Infiniti system, Alcon, USA), Longitudinal U/S (LEGACY 20000, Alcon, USA)
- Keywords
- PACHYMETRY, CELL LOSS, SAFETY, EFFICACY, PHACOEMULSIFICATION, Intraoperative complications, CLOCK TIME, FLUID USED, CORNEAL THICKNESS, ENDOTHELIUM CELL LOSS
- Medical subject headings
- Cataract, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torsional ultrasound (INFINITI, Alcon, USA)Procedure or surgery
Also called OZIL technology
Comparison of inta-operative efficacy and safety
Longitudinal U/S (Infiniti system, Alcon, USA)Procedure or surgery
Also called traditional ultrasound
comparison of efficacy and safety
Longitudinal U/S (LEGACY 20000, Alcon, USA)Procedure or surgery
Also called Traditional U/S
Interrupted energy modality
| Study group | Role | What they receive |
|---|---|---|
| Torsional ultrasound | Experimental | Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA) Receives: Procedure: Torsional ultrasound (INFINITI, Alcon, USA) |
| Longitudinal ultrasound (INFINITI) | Active comparator | Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA) Receives: Procedure: Longitudinal U/S (Infiniti system, Alcon, USA) |
| Longitudinal ultrasound (LEGACY) | Active comparator | Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA) Receives: Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative complications, surgical clock time in minutes (SCT), fluid volume in ml(FV), and central corneal thickness in µm (CCT) on day 1 and months 1 and 3, and endothelial cell density (ECD) at 3 months.
Measured: 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionMar 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- shetal m raj, ms, Principal investigator, Iladevi Cataract and IOL Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010490
- Sponsor's protocol ID
- 07-009
- Status last verified
- Nov 2009
- First submitted
- 9 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
PubMed 17276271
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Torsional Ultrasound Versus Longitudinal Ultrasound During Phacoemulsification of Age-related Cataracts: Comparison of Intra-operative Performance and Impact on Post-operative Endothelium Integrity
- ClinicalTrials.gov ID
- NCT01010490
- Acronym / sponsor ID
- 07-009
- Conditions
- Cataract
- Keywords
- PACHYMETRY, CELL LOSS, SAFETY, EFFICACY, PHACOEMULSIFICATION, Intraoperative complications, CLOCK TIME, FLUID USED
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Nov 2009 (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.
To determine the differences in intra-operative complications, surgical duration, fluid usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery and at post-operative day 1, 1 month and 3 months.
Detailed description
Introduced in mid 2006, torsional ultrasound (OZil, Infiniti Vision System, Alcon Laboratories, Texas, USA) uses rotational oscillations at ultrasonic frequencies to emulsify cataractous lens material in a seamless cutting motion from a tip that oscillates laterally. The side-to-side movement of the phaco tip produces minimal repulsion of lens material from the phaco tip resulting in improved followability. Clinically this translates into more effective lens removal with torsional phaco in comparison to the conventional ultrasound mode.to test this in a clinical scenario we undertook this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Torsional ultrasound | Experimental | Procedure: Torsional ultrasound (INFINITI, Alcon, USA)Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA) |
| Longitudinal ultrasound (INFINITI) | Active comparator | Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA) |
| Longitudinal ultrasound (LEGACY) | Active comparator | Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA) |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients 55 years and older with a senile cataract grades 1 to 5 nuclear sclerosis based on Emery's classification,
- endothelial cell density > 1500 cells/mm2,
- anterior chamber depth > 2.4 mm, and
- a dilated pupil > 7 mm.
Key exclusion criteria (4 listed)
- eyes with pseudoexfoliation,
- mature, traumatic, or complicated cataracts,
- history of previous intra-ocular surgery, glaucoma, uveitis, and
- patients who were unable to comply with follow-up examinations.
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 |
|---|---|---|
| Torsional ultrasound (INFINITI, Alcon, USA)Also: OZIL technologyComparison of inta-operative efficacy and safety | Procedure or surgery | Torsional ultrasound |
| Longitudinal U/S (Infiniti system, Alcon, USA)Also: traditional ultrasoundcomparison of efficacy and safety | Procedure or surgery | Longitudinal ultrasound (INFINITI) |
| Longitudinal U/S (LEGACY 20000, Alcon, USA)Also: Traditional U/SInterrupted energy modality | Procedure or surgery | Longitudinal ultrasound (LEGACY) |
Primary outcome
Intra-operative complications, surgical clock time in minutes (SCT), fluid volume in ml(FV), and central corneal thickness in µm (CCT) on day 1 and months 1 and 3, and endothelial cell density (ECD) at 3 months.
Time frame: 3 months post-operative
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 13 Nov 2009.
- Results publication: PubMed 17276271Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
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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.
shetal m raj, ms principal investigator
Iladevi Cataract and IOL Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Torsional ultrasound (INFINITI, Alcon, USA), Longitudinal U/S (Infiniti system, Alcon, USA) and Longitudinal U/S (LEGACY 20000, Alcon, USA) in people with Cataract, run by Iladevi Cataract and IOL Research Center at 1 site in India.
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 4 inclusion and 4 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 13 Nov 2009. 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intra-operative complications, surgical clock time in minutes (SCT), fluid volume in ml(FV), and central corneal thickness in µm (CCT) on day 1 and months 1 and 3, and endothelial cell density (ECD) at 3 months. (time frame: 3 months post-operative). 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 NCT01010490, 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 13 Nov 2009.