Clinical trial NCT02089698: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Kelman tip
Mini-flared
phacoemulsification
cataract
Lead sponsor: Hospital Oftalmologico de Brasilia
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Early Treatment Diabetic Retinopathy (ETDRS) visual acuities
timeFrame: 90 days
Secondary outcomes:
measure: Phaco time used
timeFrame: 1 day, 90 days
Other outcomes:
measure: Cumulative dissipated energy (CDE) required
timeFrame: 1 day, 90 days
Locations:
city: Brasilia
country: Brazil
facility: Hospital Oftalmologico de Brasília
state: DF
Study officials:
affiliation: Hospital Oftalmologico de Brasilia
name: Patrick F Tzelikis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.