Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00521833
First received: August 27, 2007
Last updated: September 4, 2007
Last verified: August 2007
  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: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Shahid Beheshti Medical University:

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521833

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

No publications provided

ClinicalTrials.gov Identifier: NCT00521833     History of Changes
Other Study ID Numbers: 8380
Study First Received: August 27, 2007
Last Updated: September 4, 2007
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
Kataract
Astigmatism
phacoemulsification

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014