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Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521833
First Posted: August 28, 2007
Last Update Posted: September 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.

Condition Intervention
Surrgical Induced Astigmatism Procedure: phacoemulsification and intraocular lens implantation

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Total and Surgical Induced Astigmatism [ Time Frame: At 1 and 4 weeks and 6 month after surgery ]

Enrollment: 20
Study Start Date: June 2005
Study Completion Date: August 2006
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521833


Locations
Iran, Islamic Republic of
Ophthalmic research center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Mohammad Pakravan, MD Shahid Beheshti University of Medical Sciences
  More Information

ClinicalTrials.gov Identifier: NCT00521833     History of Changes
Other Study ID Numbers: 8380
First Submitted: August 27, 2007
First Posted: August 28, 2007
Last Update Posted: September 5, 2007
Last Verified: August 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
Kataract
Astigmatism
phacoemulsification

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases


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