Effect of Posterior Corneal Toricity on Refractive Outcom... | NCT01554761

Studies
Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

NCT01554761

Sponsor

China Medical University, China

Status

Unknown status

Last Update Posted

Mar 15, 2012Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Astigmatism
Cataract

Interventions

phacoemulsification
Pentacam (Oculus,Germany)examination

Countries

China

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

May 2012Estimated

Completion Date

Not provided

First Submitted Date

Feb 27, 2012

First Submission Date that Met QC Criteria

Mar 13, 2012

First Posted Date

Mar 15, 2012Estimated

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

Mar 13, 2012

Last Update Posted Date

Mar 15, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinsong Zhang, MD,the President of Eye hosptial of China Medical Univerisity,China, China Medical University, ChinaPrincipal Investigator

Lead Sponsor

China Medical University, ChinaOTHER

Collaborators

Not provided

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

This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses.

This is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phacoemulsification	Procedure	After topical anesthesia with Alcaine, 3.0-mm clear corneal incisions were made. Torsional phacoemulsification was performed using the Infiniti Vision System with the OZil handpiece, a 45-degree Kelman miniflared tip, and DuoVisc viscoelastic (all from Alcon).
Pentacam (Oculus,Germany)examination	Device	Total corneal astigmatism is obtained by Pentacam at every visit.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pentacam-derived corneal astigmatism		3month postoperatively
refraction		3month postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cataract candidates
preoperative corneal regular astigmatism >0.75D
Willing and able to complete all required postoperative visits
Able to comprehend and sign a statement of informed consent

Exclusion Criteria:

significant intraocular lenses tilt or decentration
corneal scarring
Irregular corneal astigmatism
other ocular diseases
surgical complication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qi Sun, MD	Contact	+86 15840336028		qisun97@sina.com

Overall Officials

Name	Affiliation	Role
Jinsong Zhang, MD	Eye Hospital of China Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye hospital of China Medical Univerisity	Recruiting	Shenyang	Liaoning	110005	China

Condition Browse Module

MeSH Terms

ID	Term
D001251	Astigmatism
D002386	Cataract
D019591	Pseudophakia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases
D007905	Lens Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification

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