Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification
Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study
1 other identifier
interventional
60
1 country
1
Brief Summary
To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2013
Shorter than P25 for phase_4
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
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 12, 2014
CompletedFirst Posted
Study publicly available on registry
March 18, 2014
CompletedMarch 18, 2014
March 1, 2014
Same day
March 12, 2014
March 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early Treatment Diabetic Retinopathy (ETDRS) visual acuities
90 days
Secondary Outcomes (1)
Phaco time used
1 day, 90 days
Other Outcomes (1)
Cumulative dissipated energy (CDE) required
1 day, 90 days
Study Arms (2)
Reversed tip
ACTIVE COMPARATORReversed Kelman tip
Mini-flared
EXPERIMENTALMini-flared Kelman tip
Interventions
Eligibility Criteria
You may qualify if:
- Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Oftalmologico de Brasília
Brasília, Federal District, 70000, Brazil
Related Publications (3)
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.
PMID: 15030845RESULTPayne 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.
PMID: 16863978RESULTFrohn 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.
PMID: 12231329RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick F Tzelikis, MD, PhD
Hospital Oftalmologico de Brasilia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 12, 2014
First Posted
March 18, 2014
Study Start
September 1, 2013
Primary Completion
September 1, 2013
Study Completion
February 1, 2014
Last Updated
March 18, 2014
Record last verified: 2014-03