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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
phacoemulsification using either high vacuum or low vacuum techniques
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Phacoemulsification, Corneal endothelial cell loss, Hydrodynamic parameters, Total ultrasound energy, Total infused fluids

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alireza Baradaran Raffiee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High vacuum group

Low vacuum group

Arm Description

Those patients who underwent phacoemulsification using high hydrodynamic parameter: 400 mmHg vacuum and 40 ml/min flow rate.

Patients who underwent phacoemulsification using low hydrodynamic parameters: 200 mmHg vacuum and 20 ml/min flow rate.

Outcomes

Primary Outcome Measures

Total ultrasound energy dissipated to the eye, total infused fluid, Endothelial cell loss

Secondary Outcome Measures

Full Information

First Posted
August 31, 2006
Last Updated
December 24, 2009
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00370955
Brief Title
The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification
Official Title
The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Phacoemulsification, Corneal endothelial cell loss, Hydrodynamic parameters, Total ultrasound energy, Total infused fluids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Baradaran Raffiee, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alireza Baradaran Raffiee
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19304097?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2
Description
Published article

Learn more about this trial

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

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