The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification

Cataract Clinical Trial

Official title:

The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370955
• Other study ID #: 8527
• Status: Completed
• Phase: N/A
• First received: August 31, 2006
• Last updated: December 24, 2009
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: October 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two surgical techniques (high vacuum and low vacuum) on corneal endothelium after phacoemulsification.

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 2.5 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 > 0.4), 11- keratometric astigmatism more than 1.5 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 ml/min flow rate (high vacuum technique) whereas group 2 consisted of patients who underwent phacoemulsification using low hydrodynamic parameters: 200 mmHg vacuum and 20 ml/min 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 20ml/min, in both groups. Irrigation aspiration of cortical material and viscoelastic were bimanually and semi automatically performed with flow rate of 30ml/min.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria were:

• Moderate lens opacity (Nuclear sclerosis 3+)

• Age between 50 to 70 years

The exclusion criteria were:

• Previous corneal pathology (dystrophic or degenerative such as Fuchs' endothelial dystrophy or advanced trachoma),

• Pseudoexfoliation syndrome (PEX),

• History of intra ocular surgery,

• Glaucoma or ocular hypertension,

• Eyes with a history of anterior uveitis,

• Diabetes mellitus,

• Anterior chamber depth (ACD) less than 2.5 mm or more than 4 mm,

• Axial length less than 21 mm or more than 25 mm,

• Density of endothelial cells less than 1500 cells per mm2,

• Polymegatism (CV > 0.4),

• Keratometric astigmatism more than 1.5 Diopters (D),

• History of contact lens usage,

• Intra-operative complications (posterior capsule rupture with or without vitreous loss),

• Postoperative uveitis,

• Postoperative surgical wound leakage,

• Deep-set eye, and 17- size of dilated pupil less than 6 mm.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Cell Loss

Intervention

Procedure:
• phacoemulsification using either high vacuum or low vacuum techniques
All surgeries were performed using Sovereign phacoemulsification system (AMO) using Whitestar technology.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alireza Baradaran Raffiee	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total ultrasound energy dissipated to the eye, total infused fluid, Endothelial cell loss		All patients were examined on postoperative day 1 and weeks 1, 6 and 12.	Yes

External Links

•   Official webpage of ophthalmic research center of Shahid Beheshti University of Medical Sciences
•   Published article