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Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

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ClinicalTrials.gov Identifier: NCT00521833
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : September 5, 2007
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.

Condition or disease Intervention/treatment Phase
Surrgical Induced Astigmatism Procedure: phacoemulsification and intraocular lens implantation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2005
Actual Study Completion Date : August 2006

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



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


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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

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

ClinicalTrials.gov Identifier: NCT00521833     History of Changes
Other Study ID Numbers: 8380
First Posted: August 28, 2007    Key Record Dates
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