Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes

February 23, 2020 updated by: Sharif Yousef El Emam, Tanta University

Evaluation of Nd:YAG Laser Hyaloidotomy for Management of Premacular Subhyaloid Hemorrhage in Eyes With Proliferative Diabetic Retinopathy

Premacular Subhyaloid hemorrhage is a sudden profound loss of vision in eyes with proliferative diabetic retinopathy (PDR). Pars plana vitrectomy is the treatment of choice for premacular hemorrhage in eyes with proliferative changes. Nd:YAG laser hyaloidotomy has been used to evacuate the premacular hemorrhage

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea.
  • Eyes with proliferative diabetic retinopathy

Exclusion Criteria:

  • Dense media opacity (corneal/cataract)
  • Patients with bleeding tendency or on anti-coagulant drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity improvement
Time Frame: 1 week
Testing VA after YAG laser
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

February 23, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 23, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUOR002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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