Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

September 4, 2007 updated by: Shahid Beheshti University of Medical Sciences
To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a clinical trial, consecutive eyes with senile cataract underwent phacoemulsification with implantation of a 6.0 mm foldable hydrophobic acrylic intraocular lens through a 3.2 mm horizontal clear cornea incision at 180 degrees (temporal incision in right eyes, nasal incision in left eyes). Keratometric astigmatism was measured preoperatively and one and four weeks and 6 months after surgery. Surgically induced astigmatism (SIA) was calculated by the vector analysis method using the Holladay-Cravy-Koch formula. Patients with history of diabetes mellitus, connective tissue disorders, steroid use, previous ocular surgery, with the rule astigmatism >1D, pseudoexfoliation and any corneal pathology were excluded.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All the patients with senile cataract

Exclusion Criteria:

  • Previously operated eyes
  • Presence of corneal pathology
  • Pseudo exfoliation
  • With-the-rule (WTR) astigmatism >1 D
  • Presence of diabetes mellitus
  • History of connective tissue disease
  • Consumption of systemic steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Temporal (right eye)
Procedure: phacoemulsification and intraocular lens implantation
clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively
Experimental: 2
Nasal (Left eye)
Procedure: phacoemulsification and intraocular lens implantation
clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total and Surgical Induced Astigmatism
Time Frame: At 1 and 4 weeks and 6 month after surgery
At 1 and 4 weeks and 6 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Pakravan, MD, Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimate)

August 28, 2007

Study Record Updates

Last Update Posted (Estimate)

September 5, 2007

Last Update Submitted That Met QC Criteria

September 4, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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