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

NCT00370955 | Completed

• 1 other identifier: 8527
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

High vacuum group

ACTIVE COMPARATOR

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

Low vacuum group

ACTIVE COMPARATOR

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

Interventions

phacoemulsification using either high vacuum or low vacuum techniques PROCEDURE

All surgeries were performed using Sovereign phacoemulsification system (AMO) using Whitestar technology.

Also known as: stop and chop technique

High vacuum group; Low vacuum group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate lens opacity (Nuclear sclerosis 3+)
• Age between 50 to 70 years

You may not qualify if:

• 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,

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Alireza Baradaran Raffiee

Tehran, Tehran Province, 16666, Iran

Location

Related Links

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

MeSH Terms

Conditions

Cataract; Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Corneal Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Alireza Baradaran Raffiee, MD

  Ophthalmic Research Center of Shaheed Beheshti Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2006
• First Posted: September 1, 2006
• Study Start: March 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 25, 2009

Record last verified: 2008-10

Locations

IR (1)