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

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: phacoemulsification using either high vacuum or low vacuum techniques

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 16666
    • Alireza Baradaran Raffiee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: stop and chop technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Principal Investigator: Alireza Baradaran Raffiee, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University

Publications and helpful links

Helpful Links

• Published article

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: August 31, 2006
• First Submitted That Met QC Criteria: August 31, 2006
• First Posted (Estimate): September 1, 2006

Study Record Updates

• Last Update Posted (Estimate): December 25, 2009
• Last Update Submitted That Met QC Criteria: December 24, 2009
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Phacoemulsification; Corneal endothelial cell loss; Hydrodynamic parameters; Total ultrasound energy; Total infused fluids
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Postoperative Complications; Lens Diseases; Corneal Diseases; Eye Manifestations; Cataract; Corneal Endothelial Cell Loss
• Other Study ID Numbers: 8527