N/A N=120

Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT01429532 ↗

Enrolled (actual)

120

Serious AEs

—

Results posted

Jul 2014

Primary outcome: Primary: Central Cornea Endothelial Cell Loss — 11.78; 13.03; 12.05; 7.77 % of endothelial cell loss

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: phacoemulsification (Procedure)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Sun Yat-sen University
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Central Cornea Endothelial Cell Loss	11.78; 13.03; 12.05; 7.77; 9.35; 7.93	—
PRIMARY Surgically Induced Astigmatism	1.2; 0.91; 0.951; 0.61; 0.74; 0.79	—
SECONDARY Best-corrected Visual Acuity	0.16; 0.13; 0.15; 0.66; 0.71; 0.73	—

Summary

The purpose of this study is to compare the outcomes of cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).

Eligibility Criteria

Inclusion Criteria

age between 55 and 85 years
the presence of nuclear or cortex-nuclear cataract, grades 2.0 to 4.0 (Lens Opacities Classification System III)
a transparent central cornea
pupil dilating to >= 7 mm at the time of preoperative examination
a preoperative central endothelial cell count of >= 1500 cells per square millimeter

Exclusion Criteria

previous intraocular surgery
glaucoma
pseudoexfoliation
uveitis
high myopia
diabetes mellitus

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01429532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.