Outcomes of Phacoemulsification With Torsional Ultrasound
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
1 other identifier
interventional
360
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2007
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
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 9, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedNovember 13, 2009
November 1, 2009
1.6 years
November 9, 2009
November 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months post-operative
Study Arms (3)
Torsional ultrasound
EXPERIMENTALTorsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA)
Longitudinal ultrasound (INFINITI)
ACTIVE COMPARATORLongitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA)
Longitudinal ultrasound (LEGACY)
ACTIVE COMPARATORLongitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA)
Interventions
Comparison of inta-operative efficacy and safety
comparison of efficacy and safety
Interrupted energy modality
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raghudeep eye clinic
Ahmedabad, Gujarat, 52, India
Related Publications (1)
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.
PMID: 17276271RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
shetal m raj, ms
Iladevi Cataract and IOL Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 9, 2009
First Posted
November 10, 2009
Study Start
May 1, 2007
Primary Completion
December 1, 2008
Study Completion
March 1, 2009
Last Updated
November 13, 2009
Record last verified: 2009-11