Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Mini-flared
Reversed tip
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Kelman tip, Mini-flared, phacoemulsification, cataract
Eligibility Criteria
Inclusion Criteria:
- Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.
Exclusion Criteria:
- Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded
Sites / Locations
- Hospital Oftalmologico de Brasília
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Reversed tip
Mini-flared
Arm Description
Reversed Kelman tip
Mini-flared Kelman tip
Outcomes
Primary Outcome Measures
Early Treatment Diabetic Retinopathy (ETDRS) visual acuities
Secondary Outcome Measures
Phaco time used
Full Information
NCT ID
NCT02089698
First Posted
March 12, 2014
Last Updated
March 15, 2014
Sponsor
Hospital Oftalmologico de Brasilia
1. Study Identification
Unique Protocol Identification Number
NCT02089698
Brief Title
Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification
Official Title
Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Oftalmologico de Brasilia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.
Detailed Description
In this prospective, comparative, masked study, patients will be randomly assigned to have torsional coaxial microincision cataract surgery using either the mini-flared 45-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT). Intraoperative measurements will include phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).
The study was performed according to established ethical standards for clinical research Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between November 2010 and February of 2011. All surgeries will be performed at the University of Sao Paulo. Physicians conducting postoperative evaluation will not have access to patients' medical records. Exclusion criteria will be previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will be subsequently excluded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Kelman tip, Mini-flared, phacoemulsification, cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reversed tip
Arm Type
Active Comparator
Arm Description
Reversed Kelman tip
Arm Title
Mini-flared
Arm Type
Experimental
Arm Description
Mini-flared Kelman tip
Intervention Type
Device
Intervention Name(s)
Mini-flared
Intervention Description
Mini-flared Kelman tip
Intervention Type
Device
Intervention Name(s)
Reversed tip
Intervention Description
Reversed Kelman tip
Primary Outcome Measure Information:
Title
Early Treatment Diabetic Retinopathy (ETDRS) visual acuities
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Phaco time used
Time Frame
1 day, 90 days
Other Pre-specified Outcome Measures:
Title
Cumulative dissipated energy (CDE) required
Time Frame
1 day, 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.
Exclusion Criteria:
Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick F Tzelikis, MD, PhD
Organizational Affiliation
Hospital Oftalmologico de Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Oftalmologico de Brasília
City
Brasilia
State/Province
DF
ZIP/Postal Code
70000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
15030845
Citation
Vargas LG, Holzer MP, Solomon KD, Sandoval HP, Auffarth GU, Apple DJ. Endothelial cell integrity after phacoemulsification with 2 different handpieces. J Cataract Refract Surg. 2004 Feb;30(2):478-82. doi: 10.1016/S0886-3350(03)00620-5.
Results Reference
result
PubMed Identifier
16863978
Citation
Payne M, Georgescu D, Waite AN, Olson RJ. Phacoemulsification tip vacuum pressure: Comparison of 4 devices. J Cataract Refract Surg. 2006 Aug;32(8):1374-7. doi: 10.1016/j.jcrs.2006.02.066.
Results Reference
result
PubMed Identifier
12231329
Citation
Frohn A, Dick HB, Fritzen CP. Corneal impact of ultrasound and bevel position in phacoemulsification. J Cataract Refract Surg. 2002 Sep;28(9):1667-70. doi: 10.1016/s0886-3350(02)01306-8.
Results Reference
result
Learn more about this trial
Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification
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