NCT02555956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

August 6, 2015

Last Update Submit

September 20, 2015

Conditions

Diabetic Macular Edema

Keywords

Macular gridSubthresholddiabetic macular edemadecrease in visual acuity

Outcome Measures

Primary Outcomes (1)

  • Improvement of visual acuity after grid laser

    Visual acuity will be mesured pre laser and 06 weeks post laser

    6 week

Secondary Outcomes (1)

  • Complication

    during first six weeks after laser

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patients having diffuse diabetic macular edema.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow universty Hospital,Dow international Medical college

Karachi, Sindh, 75500, Pakistan

Location

Study Officials

  • Dr. Jamshed Ahmed, FCPS

    Dow university of health sciences, karachi

    PRINCIPAL INVESTIGATOR

  • Jamshed Ahmed, FCPS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 6, 2015

First Posted

September 22, 2015

Study Start

April 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

PA(1)