Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

Surrgical Induced Astigmatism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521833
• Other study ID #: 8380
• Status: Completed
• Phase: N/A
• First received: August 27, 2007
• Last updated: September 4, 2007
• Start date: June 2005
• Est. completion date: August 2006

Study information

• Verified date: August 2007
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Surrgical Induced Astigmatism

Intervention

Procedure:
• phacoemulsification and intraocular lens implantation
clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic research center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total and Surgical Induced Astigmatism		At 1 and 4 weeks and 6 month after surgery