Proliferative Diabetic RetinopathyNCT04285151
Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes
A study testing Nd:YAG laser Hyaloidotomy in people with Proliferative Diabetic Retinopathy, run by Tanta University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Nd:YAG laser Hyaloidotomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2020
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea.
- Eyes with proliferative diabetic retinopathy
Who cannot join
- Dense media opacity (corneal/cataract)
- Patients with bleeding tendency or on anti-coagulant drugs
About this study
Official title: 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
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Nd:YAG laser Hyaloidotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd:YAG laser HyaloidotomyProcedure or surgery
Using the YAG laser for opening the posterior hyaloid in eyes with premacular hemorrhage, and evacuating the entrapped hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity improvement
Testing VA after YAG laser
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study startJan 2015
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharif Yousef El Emam, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285151
- Sponsor's protocol ID
- TUOR002
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nd:YAG Laser Hyaloidotomy for Management of Premacular Subhyaloid Hemorrhage in Eyes With Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04285151
- Acronym / sponsor ID
- TUOR002
- Conditions
- Proliferative Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 26 Feb 2020 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea.
- Eyes with proliferative diabetic retinopathy
Key exclusion criteria (2 listed)
- Dense media opacity (corneal/cataract)
- Patients with bleeding tendency or on anti-coagulant drugs
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 |
|---|---|---|
| Nd:YAG laser HyaloidotomyUsing the YAG laser for opening the posterior hyaloid in eyes with premacular hemorrhage, and evacuating the entrapped hemorrhage | Procedure or surgery | – |
Primary outcome
Visual acuity improvement
Time frame: 1 week
Testing VA after YAG laser
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nd:YAG laser Hyaloidotomy in people with Proliferative Diabetic Retinopathy, run by Tanta University.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity improvement (time frame: 1 week). 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 26 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.