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

• ClinicalTrials.gov Identifier: NCT00370955
• Recruitment Status: Completed
• First Posted: September 1, 2006
• Last Update Posted: December 25, 2009
• Sponsor: Shahid Beheshti University of Medical Sciences
• Information provided by: Shahid Beheshti University of Medical Sciences

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cataract	Procedure: phacoemulsification using either high vacuum or low vacuum techniques	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification
• Study Start Date: March 2007
• Actual Primary Completion Date: August 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: High vacuum group; Those patients who underwent phacoemulsification using high hydrodynamic parameter: 400 mmHg vacuum and 40 ml/min flow rate.	Procedure: phacoemulsification using either high vacuum or low vacuum techniques; All surgeries were performed using Sovereign phacoemulsification system (AMO) using Whitestar technology.; Other Name: stop and chop technique
Active Comparator: Low vacuum group; Patients who underwent phacoemulsification using low hydrodynamic parameters: 200 mmHg vacuum and 20 ml/min flow rate.	Procedure: phacoemulsification using either high vacuum or low vacuum techniques; All surgeries were performed using Sovereign phacoemulsification system (AMO) using Whitestar technology.; Other Name: stop and chop technique

Outcome Measures

Primary Outcome Measures :

1. Total ultrasound energy dissipated to the eye, total infused fluid, Endothelial cell loss [ Time Frame: All patients were examined on postoperative day 1 and weeks 1, 6 and 12. ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Iran, Islamic Republic of

Alireza Baradaran Raffiee

Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

• Principal Investigator: Alireza Baradaran Raffiee, MD; Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

Additional Information:

Official webpage of ophthalmic research center of Shahid Beheshti University of Medical Sciences 

Published article 

• Responsible Party: Ophthalmic Research Center of Shaheed Beheshti Medical University, Shaheed Beheshti Medical University
• ClinicalTrials.gov Identifier: NCT00370955
• Other Study ID Numbers: 8527
• First Posted: September 1, 2006
• Last Update Posted: December 25, 2009
• Last Verified: October 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:

Phacoemulsification; Corneal endothelial cell loss; Hydrodynamic parameters; Total ultrasound energy; Total infused fluids

Additional relevant MeSH terms:

Cataract; Corneal Endothelial Cell Loss; Lens Diseases; Eye Diseases; Corneal Diseases; Postoperative Complications; Pathologic Processes