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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370955
First received: August 31, 2006
Last updated: December 24, 2009
Last verified: October 2008
  Purpose

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


Condition Intervention
Cataract
Procedure: phacoemulsification using either high vacuum or low vacuum techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Hydrodynamic Parameters on Corneal Endothelial Cell Loss After Phacoemulsification

Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00370955

Locations
Iran, Islamic Republic of
Alireza Baradaran Raffiee
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti Medical University
Investigators
Principal Investigator: Alireza Baradaran Raffiee, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

Additional Information:
No publications provided

Responsible Party: Ophthalmic Research Center of Shaheed Beheshti Medical University, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00370955     History of Changes
Other Study ID Numbers: 8527
Study First Received: August 31, 2006
Last Updated: December 24, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
Phacoemulsification
Corneal endothelial cell loss
Hydrodynamic parameters
Total ultrasound energy
Total infused fluids

Additional relevant MeSH terms:
Corneal Endothelial Cell Loss
Corneal Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014