Assessment of Color Vision in Diabetic Patients | NCT03345667

Studies
Assessment of Color Vision in Diabetic Patients

NCT03345667

Sponsor

Instituto de Olhos de Goiania

Status

Completed

Last Update Posted

Nov 17, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Retinopathy, Diabetic

Interventions

lucentis

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 2017

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 1, 2017Actual

Primary Completion Date

Oct 1, 2017Actual

Completion Date

Oct 30, 2017Actual

First Submitted Date

Nov 7, 2017

First Submission Date that Met QC Criteria

Nov 16, 2017

First Posted Date

Nov 17, 2017Actual

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 16, 2017

Last Update Posted Date

Nov 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema

Detailed Description

Not provided

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anti-Vegf		Use intravitreous anti-vegf	Drug: lucentis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lucentis	Drug	Use of lucentis and other anti-vegf in patients with diabetic retinopathy	Anti-Vegf

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema	Using the Ishihara's test to analise the possible loss of vision	3 months

Secondary Outcomes

Measure	Description	Time Frame
Frame between the injections	Ant-Vegf	1 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having diabetic retinopathy with macular edema

Exclusion Criteria:

Not having diabetic retinopathy with macular edema

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema. Using the Ishirara's test to evaluate the possible visual loss.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided