Outcomes of Phacoemulsification With Torsional Ultrasound
This study has been completed.
Sponsor:
Iladevi Cataract and IOL Research Center
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01010490
First received: November 9, 2009
Last updated: November 11, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Procedure: Torsional ultrasound (INFINITI, Alcon, USA) Procedure: Longitudinal U/S (Infiniti system, Alcon, USA) Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cataract
Drug Information available for:
Dipivefrin hydrochloride
U.S. FDA Resources
Further study details as provided by Iladevi Cataract and IOL Research Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 360 |
| Study Start Date: | May 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Torsional ultrasound
Torsional ultrasound with the INFINITI phacoemulsification system (Alcon Lab, USA)
|
Procedure: Torsional ultrasound (INFINITI, Alcon, USA)
Comparison of inta-operative efficacy and safety
Other Name: OZIL technology
|
|
Active Comparator: Longitudinal ultrasound (INFINITI)
Longitudinal ultrasound with the INFINITI phacomachine (Alcon Lab, USA)
|
Procedure: Longitudinal U/S (Infiniti system, Alcon, USA)
comparison of efficacy and safety
Other Name: traditional ultrasound
|
|
Active Comparator: Longitudinal ultrasound (LEGACY)
Longitudinal ultrasound with the LEGACY phacomachine (Alcon Lab, USA)
|
Procedure: Longitudinal U/S (LEGACY 20000, Alcon, USA)
Interrupted energy modality
Other Name: Traditional U/S
|
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.
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010490
Locations
| India | |
| Raghudeep eye clinic | |
| Ahmedabad, Gujarat, India, 52 | |
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
| Principal Investigator: | shetal m raj, ms | Iladevi Cataract and IOL Research Center |
More Information
Publications:
| Responsible Party: | Dr. Shetal Raj, Raghudeep eye clinic |
| ClinicalTrials.gov Identifier: | NCT01010490 History of Changes |
| Other Study ID Numbers: | 07-009 |
| Study First Received: | November 9, 2009 |
| Last Updated: | November 11, 2009 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Iladevi Cataract and IOL Research Center:
|
PACHYMETRY CELL LOSS SAFETY EFFICACY PHACOEMULSIFICATION |
Intraoperative complications CLOCK TIME FLUID USED CORNEAL THICKNESS ENDOTHELIUM CELL LOSS |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases Dipivefrin Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013