Surgically Induced Astigmatism of Temporal Versus Nasal C... | NCT00521833

Studies
Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification

NCT00521833

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Sep 5, 2007Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Surrgical Induced Astigmatism

Interventions

phacoemulsification and intraocular lens implantation

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Aug 2006Actual

First Submitted Date

Aug 27, 2007

First Submission Date that Met QC Criteria

Aug 27, 2007

First Posted Date

Aug 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2007

Last Update Posted Date

Sep 5, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Temporal (right eye)	Procedure: phacoemulsification and intraocular lens implantation
2	Experimental	Nasal (Left eye)	Procedure: phacoemulsification and intraocular lens implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phacoemulsification and intraocular lens implantation	Procedure	clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total and Surgical Induced Astigmatism		At 1 and 4 weeks and 6 month after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad Pakravan, MD	Shahid Beheshti University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic research center		Tehran	Tehran Province	16666	Iran

ID	Term
D001251	Astigmatism

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification
D019654	Lens Implantation, Intraocular

Ancestor Terms

ID	Term
D002387	Cataract Extraction
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided