Panretinal Photocoagulation During Vitrectomy for Diabeti... | NCT05318742

Studies
Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

NCT05318742

Sponsor

Panhandle Eye Group, LLP

Status

Unknown status

Last Update Posted

Apr 8, 2022Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Diabetic Vitreous Hemorrhage

Interventions

laser

Countries

Mexico

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

Jan 15, 2024Estimated

Completion Date

Jan 15, 2024Estimated

First Submitted Date

Jan 1, 2022

First Submission Date that Met QC Criteria

Apr 6, 2022

First Posted Date

Apr 8, 2022Actual

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

Apr 6, 2022

Last Update Posted Date

Apr 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In this randomized clinical trial, the authors compare two cohorts receiving different endolaser spot amounts with similar laser settings in PDR subjects naïve to PRP undergoing PPV for the indication of VH.

Detailed Description

Enrolled patients will be randomized into 1 of 2 possible treatment groups: Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV, whereas Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV. Simple randomization will allocate subjects into treatment groups during PPV. Once all applicable maneuvers (including satisfactory hemostasis) are completed by the surgeon apart from endolaser PRP, a coin toss simulation program will randomize subjects into treatment groups.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fewer Laser Spots	Active Comparator	Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV	Procedure: laser
Higher Laser Spots	Active Comparator	Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV	Procedure: laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laser	Procedure	Endolaser photocoagulation during PPV	Fewer Laser Spots Higher Laser Spots

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Vitreous Hemorrhage	The primary outcome measure of the trial was the incidence of postoperative VH during the 6-month trial period between treatment groups	6 months

Secondary Outcomes

Measure	Description	Time Frame
Postoperative LogMAR visual acuity	6 month LogMAR visual acuity between groups	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject has type I or II diabetes mellitus
The age of the subject is > 18 years old
Snellen best-corrected visual acuity ranges from 20/40 to hand motions at one foot in the research eye
Proliferative diabetic retinopathy with a vitreous hemorrhage is present in the research eye, and the vitreous hemorrhage is considered to be the primary cause for the subject's reduced vision
The subject is panretinal photocoagulation-naïve
The vitreoretinal adhesion is Grade 0 or 1 according to the classification system published by Ahn et al in the research eye

Exclusion Criteria:

The research eye had formerly undergone anterior or posterior vitrectomy.
An opacity of the anterior segment (cornea or lens) is thought to be responsible for two or more lines of decreased visual acuity in the research eye (cataract, corneal scar, ectasia, etc.)
Optic nerve or retina disease unconnected to diabetes mellitus is thought to be responsible for two or more lines of decreased visual acuity in the research eye (optic neuritis, macular degeneration, glaucoma, etc.)
Amblyopia or a non-ocular source (i.e., cerebrovascular accident) is considered to be responsible for two or more lines of decreased visual acuity in the research eye
Neovascular glaucoma with an elevated intraocular pressure (> 30 mm Hg) is present in the research eye
Uncontrolled systemic hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) is present

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Christi Rush	Contact	8066740200		christirush123@gmail.com
Sloan Rush, MD	Contact	8066740200		sloan.rush@paneye.com

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies