Different Surgical Techniques for Pterygium Surgery | NCT02002338

Studies
Different Surgical Techniques for Pterygium Surgery

NCT02002338

Sponsor

Instituto de Olhos de Goiania

Status

Completed

Last Update Posted

Dec 5, 2013Estimated

Enrollment

38Actual

Phase

Not provided

Conditions

Pterygium

Interventions

Not provided

Countries

Brazil

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

Nov 2013

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

Feb 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Nov 30, 2013

First Submission Date that Met QC Criteria

Nov 30, 2013

First Posted Date

Dec 5, 2013Estimated

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

Nov 30, 2013

Last Update Posted Date

Dec 5, 2013Estimated

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

A study to research the post-operative results according to the chosen surgical technique and evaluate the refractive changes before and after the excision of pterygium.

Detailed Description

To analyze the epidemiological profile of patients who were operated of pterygium in Eyes Institute of Goiânia, analyze the post-operative results according to the chosen surgical technique and evaluate the refractive changes before and after the excision of pterygium.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

38Actual

Label	Type	Description	Intervention Names
Pterygium		Patients who were operated of pterygium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Refractive pre-operative	Refractive before the excision of pterygium	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Refractive post-operative	Refractive after the excision of pterygium	8 weeks

Other Outcomes

Measure	Description	Time Frame
Comparison between different surgical techniques for pterygium surgery	To analyze the post-operative results according to the chosen surgical technique and evaluate the refractive changes before and after the excision of pterygium	6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who were underwent the pterygium surgery during the period between from February 2013 to August 2013

Exclusion Criteria:

Patients with mature cataract

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals who were underwent pterygium surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adriana R Almeida, MS-V	Instituto de Olhos de Goiania	Study Chair
Larissa S Stival, MD	Instituto de Olhos de Goiania	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Olhos de Goiania		Goiânia	Goiás	74110120	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D011625	Pterygium

Ancestor Terms

ID	Term
D003229	Conjunctival Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided