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Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

Primary Purpose

Surrgical Induced Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

phacoemulsification and intraocular lens implantation

About this trial

This is an interventional treatment trial for Surrgical Induced Astigmatism focused on measuring Kataract, Astigmatism, phacoemulsification

Eligibility Criteria

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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

Sites / Locations

Ophthalmic research center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Temporal (right eye)

Nasal (Left eye)

Outcomes

Primary Outcome Measures

Total and Surgical Induced Astigmatism

Secondary Outcome Measures

Full Information

NCT ID

NCT00521833

First Posted

August 27, 2007

Last Updated

September 4, 2007

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00521833

Brief Title

Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surrgical Induced Astigmatism

Keywords

Kataract, Astigmatism, phacoemulsification

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Temporal (right eye)

Arm Title

Arm Type

Experimental

Arm Description

Nasal (Left eye)

Intervention Type

Procedure

Intervention Name(s)

phacoemulsification and intraocular lens implantation

Intervention Description

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

Primary Outcome Measure Information:

Title

Total and Surgical Induced Astigmatism

Time Frame

At 1 and 4 weeks and 6 month after surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad Pakravan, MD

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmic research center

City

Tehran

ZIP/Postal Code

16666

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

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