Pseudoexfoliation Syndrome in Myopes | NCT01637740

Studies
Pseudoexfoliation Syndrome in Myopes

NCT01637740

Sponsor

General Hospital Sveti Duh

Status

Completed

Last Update Posted

Jul 11, 2012Estimated

Enrollment

5,753Actual

Phase

Not provided

Conditions

Pseudoexfoliation Syndrome in Cataract Myopic Eyes

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
04072012UECUHSD	Other Identifier	University Eye Clinic, University Hospital "Sveti Duh"

Status Module

Record Verification Date

Jul 2012

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

Aug 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jul 7, 2012

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 11, 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

Jul 10, 2012

Last Update Posted Date

Jul 11, 2012Estimated

Description Module

Brief Summary

A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic. Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with those of cataract myopic eyes group without pseudoexfoliation syndrome.

Detailed Description

A retrospective study of 5753 eyes of cataract surgery patients was conducted at investigators Clinic in a period of 2.5 years. Pseudoexfoliation syndrome was found in 255 eyes. There were only 26 cataract myopic eyes with pseudoexfoliation syndrome. Refractive eye state was defined by preoperatively calculated emmetropization intraocular lens (IOL) value done by optical low coherence reflectometry biometer LENSTAR LS 900®. Ocular optical components of the cataract myopic eyes with pseudoexfoliation syndrome measured by this biometer were put in comparison with matched cataract myopic eyes group without pseudoexfoliation syndrome that have emmetropization IOL value within the same range as the cataract myopic eyes with pseudoexfoliation syndrome.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,753Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
eyes with pseudoexfoliation syndrome		cataract myopic eyes with pseudoexfoliation syndrome
eyes without pseudoexfoliation syndrome		cataract myopic eyes without pseudoexfoliation syndrome

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cataract surgery patients ≥ 40 years old

Exclusion Criteria:

cataract surgery patients < 40 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

5753 eyes of cataract surgery patients ≥ 40 years old

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia
D017889	Exfoliation Syndrome
D002386	Cataract

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases
D007499	Iris Diseases
D014603	Uveal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided