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Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Primary Purpose

Diabetic Vitreous Hemorrhage

Status

Recruiting

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

laser

About this trial

This is an interventional treatment trial for Diabetic Vitreous Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

La Carlota HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Fewer Laser Spots

Higher Laser Spots

Arm Description

Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV

Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative LogMAR visual acuity

6 month LogMAR visual acuity between groups

Full Information

NCT ID

NCT05318742

First Posted

January 1, 2022

Last Updated

April 6, 2022

Sponsor

Panhandle Eye Group, LLP

1. Study Identification

Unique Protocol Identification Number

NCT05318742

Brief Title

Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Official Title

Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial Comparing Treatment Amount

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 15, 2022 (Actual)

Primary Completion Date

January 15, 2024 (Anticipated)

Study Completion Date

January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Panhandle Eye Group, LLP

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Vitreous Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fewer Laser Spots

Arm Type

Active Comparator

Arm Description

Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV

Arm Title

Higher Laser Spots

Arm Type

Active Comparator

Arm Description

Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV

Intervention Type

Procedure

Intervention Name(s)

laser

Intervention Description

Endolaser photocoagulation during PPV

Primary Outcome Measure Information:

Title

Postoperative Vitreous Hemorrhage

Description

The primary outcome measure of the trial was the incidence of postoperative VH during the 6-month trial period between treatment groups

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Postoperative LogMAR visual acuity

Description

6 month LogMAR visual acuity between groups

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christi Rush

Phone

8066740200

christirush123@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sloan Rush, MD

Phone

8066740200

sloan.rush@paneye.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sloan Rush, MD

Organizational Affiliation

panhandle eye group

Official's Role

Study Director

Facility Information:

Facility Name

La Carlota Hospital

City

Montemorelos

State/Province

Nuevo Leon

ZIP/Postal Code

67512

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sloan Rush, MD

Phone

8066740200

sloan.rush@paneye.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

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