Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00521833
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2005
• Actual Study Completion Date: Aug 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Total and Surgical Induced Astigmatism [At 1 and 4 weeks and 6 month after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00521833
• Other Study ID Numbers: 8380
• First Posted: Aug 28, 2007
• Last Update Posted: Sep 5, 2007
• Last Verified: Aug 1, 2007

• Keywords provided by , ,: Kataract; Astigmatism; phacoemulsification
• Additional relevant MeSH terms: Astigmatism

Study Results

No Results Posted as of Sep 5, 2007