Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370955
Status:
COMPLETED
Last Update Posted:
2009-12-25
First Post:
2006-08-31
Brief Title:
The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare two surgical techniques high vacuum and low vacuum on corneal endothelium after phacoemulsification
Detailed Description:
Patients aged 50 to 70 years old with moderate lens opacities nuclear sclerosis of 3 were included The exclusion criteria were 1-previous corneal pathology dystrophic or degenerative such as Fuchs endothelial dystrophy or advanced trachoma 2- pseudoexfoliation syndrome PEX 3- history of intra ocular surgery 4- glaucoma or ocular hypertension 5- eyes with a history of anterior uveitis 6- diabetes mellitus 7- anterior chamber depth ACD less than 25 mm or more than 4 mm 8- axial length less than 21 mm or more than 25 mm 9- density of endothelial cells less than 1500 cells per mm2 10- polymegatism CV 04 11- keratometric astigmatism more than 15 Diopters D 12- history of contact lens usage 13- Intra-operative complications posterior capsule rupture with or without vitreous loss 14- postoperative uveitis 15- postoperative surgical wound leakage 16- deep-set eye and 17- size of dilated pupil less than 6 mm Nucleus density was evaluated using the LOCS III classification system Patients were divided in 2 groups randomly Group 1 included those candidates for phacoemulsification using high hydrodynamic parameter 400 mmHg vacuum and 40 mlmin flow rate high vacuum technique whereas group 2 consisted of patients who underwent phacoemulsification using low hydrodynamic parameters 200 mmHg vacuum and 20 mlmin flow rate low vacuum technique All surgeries were performed by one surgeon using stop and chop technique with sovereign white star technology AMO USA During sculpting stage vacuum was 40mmHg and flow rate is 20mlmin in both groups Irrigation aspiration of cortical material and viscoelastic were bimanually and semi automatically performed with flow rate of 30mlmin
Total ultrasound power and total volume of BSS in both groups were measured Pachymetry endothelial cell density polymegathism before and 1 6 and 12 weeks after intervention were also evaluated Statistically analysis of data included univariate student t-test and x2 and multivariate regression model analysis of postoperative results
Total ultrasound power and total volume of BSS in both groups were measured Pachymetry endothelial cell density polymegathism before and 1 6 and 12 weeks after intervention were also evaluated Statistically analysis of data included univariate student t-test and x2 and multivariate regression model analysis of postoperative results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None