Diabetic Vitreous HemorrhageNCT05318742
Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage
A study testing laser in people with Diabetic Vitreous Hemorrhage, run by Panhandle Eye Group, LLP at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Vitreous Hemorrhage
- What is being tested?
- laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 15 Feb 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
La Carlota Hospital
Montemorelos, Nuevo León, 67512
Sloan Rush, MD, 8066740200, sloan.rush@paneye.com
About this study
Official title: Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial Comparing Treatment Amount
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.
Read the 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.
- Conditions
- Diabetic Vitreous Hemorrhage
- Being tested
- laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laserProcedure or surgery
Endolaser photocoagulation during PPV
| Study group | Role | What they receive |
|---|---|---|
| Fewer Laser Spots | Active comparator | Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV Receives: Procedure: laser |
| Higher Laser Spots | Active comparator | Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV Receives: Procedure: laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Postoperative LogMAR visual acuity
6 month LogMAR visual acuity between groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start15 Feb 2022
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Vitreous HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panhandle Eye Group, LLP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sloan Rush, MD, Study director, panhandle eye group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318742
- Sponsor's protocol ID
- Protocol 0022
- Status last verified
- Apr 2022
- First submitted
- 1 Jan 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial Comparing Treatment Amount
- ClinicalTrials.gov ID
- NCT05318742
- Acronym / sponsor ID
- Protocol 0022
- Conditions
- Diabetic Vitreous Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Panhandle Eye Group, LLPUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fewer Laser Spots | Active comparator | Procedure: laserGroup A patients underwent endolaser PRP with a range of 200-300 shots during PPV |
| Higher Laser Spots | Active comparator | Procedure: laserGroup B patients underwent endolaser PRP with a range of 500-600 shots during PPV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laserEndolaser photocoagulation during PPV | Procedure or surgery | Fewer Laser Spots, Higher Laser Spots |
Primary outcome
Postoperative Vitreous Hemorrhage
Time frame: 6 months
The primary outcome measure of the trial was the incidence of postoperative VH during the 6-month trial period between treatment groups
1 secondary outcome
Postoperative LogMAR visual acuity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Diabetic Vitreous Hemorrhage
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Cataract, Vitreous Hemorrhage
Not yet recruitingPhase 4
Continuous Delivery of Ranibizumab Via the Port Delivery System for Proliferative Diabetic Retinopathy-related Vitreous Hemorrhage With Pars Plana Vitrectomy and Limited PRP.
Proliferative Diabetic Retinopathy, Diabetic Retinopathy
Enrolling by invitationPhase 4
Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy
Diabetic Retinopathy, Vitreous Hemorrhage Due to Diabetes Mellitus
Recruiting
Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
Proliferative Diabetic Retinopathy - High Risk
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sloan Rush, MD study director
panhandle eye group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser in people with Diabetic Vitreous Hemorrhage, run by Panhandle Eye Group, LLP at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christi Rush (8066740200, christirush123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Vitreous Hemorrhage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.