Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification
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ClinicalTrials.gov Identifier: NCT02089698 |
Recruitment Status :
Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
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Condition or disease | Intervention/treatment | Phase |
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Cataract | Device: Mini-flared Device: Reversed tip | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | February 2014 |
Arm | Intervention/treatment |
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Active Comparator: Reversed tip
Reversed Kelman tip
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Device: Mini-flared
Mini-flared Kelman tip |
Experimental: Mini-flared
Mini-flared Kelman tip
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Device: Reversed tip
Reversed Kelman tip |
- Early Treatment Diabetic Retinopathy (ETDRS) visual acuities [ Time Frame: 90 days ]
- Phaco time used [ Time Frame: 1 day, 90 days ]
- Cumulative dissipated energy (CDE) required [ Time Frame: 1 day, 90 days ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089698
Brazil | |
Hospital Oftalmologico de Brasília | |
Brasilia, DF, Brazil, 70000 |
Principal Investigator: | Patrick F Tzelikis, MD, PhD | Hospital Oftalmologico de Brasilia |
Responsible Party: | PATRICK FRENSEL DE MORAES TZELIKIS, Principal Investigator, Hospital Oftalmologico de Brasilia |
ClinicalTrials.gov Identifier: | NCT02089698 |
Other Study ID Numbers: |
2014.03 |
First Posted: | March 18, 2014 Key Record Dates |
Last Update Posted: | March 18, 2014 |
Last Verified: | March 2014 |
Kelman tip Mini-flared phacoemulsification cataract |
Cataract Lens Diseases Eye Diseases |