Grid Laser for Diffuse Diabetic Maculopathy | NCT02555956

Studies
Grid Laser for Diffuse Diabetic Maculopathy

NCT02555956

Sponsor

Dow University of Health Sciences

Status

Completed

Last Update Posted

Sep 22, 2015Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Diabetic Macular Edema

Interventions

Not provided

Countries

Pakistan

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

Sep 2015

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

Apr 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Aug 6, 2015

First Submission Date that Met QC Criteria

Sep 20, 2015

First Posted Date

Sep 22, 2015Estimated

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 20, 2015

Last Update Posted Date

Sep 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jamshed Ahmed, Assistant Professor, Dow University of Health SciencesPrincipal Investigator

Lead Sponsor

Dow University of Health SciencesOTHER

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

Diabetic related complications are increasing day by day due to increse in the number of diabetic patients all over the world. Diabetic macular edema is one of them and a major cause of vision imparment. Various kind of treatment modalities are preent to treat this coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive procedure.Laser power if kept to aminimum can get the desired results without severe destruction to the retina . In this study, the investigators are going to document the effect of minimal grid laser tn loss o overcome the visioe to 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

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

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of visual acuity after grid laser	Visual acuity will be mesured pre laser and 06 weeks post laser	6 week

Secondary Outcomes

Measure	Description	Time Frame
Complication	Patiens willbe asked and examined for any potentiail anticipated complication.	during first six weeks after laser

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic patients with macular edema.
both sexes
conset to participate.

Exclusion Criteria:

focal edema.
patients requiring only the focal laser.
patients with proferative diabetic retinopathy.
Patients with ischaemic maculopathy on fundus fluorescein angiography.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Diabetic patients having diffuse diabetic macular edema.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Jamshed Ahmed, FCPS	Dow university of health sciences, karachi	Principal Investigator
Jamshed Ahmed, FCPS	Dow University of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dow universty Hospital,Dow international Medical college		Karachi	Sindh	75500	Pakistan