Diabetic Macular EdemaNCT03384901
The Results of Pars Plana Vitrectomy in Diabetic Macular Edema
An observational study of Diabetic Macular Edema, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This study will be a retrospective analysis of vitrectomy results in patients suffering from diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2018to Jan 2019
- Phase
- Observational
- 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
Study population: Patients attending the Hillel Yaffe Medical Center Ophthalmology Clinic
Who may be able to join
- Diabetic macular edema patients after vitrectomy
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hille Yaffe Medical Center
Hadera, 38100
Eran Berkowitz, MD, eranberko@gmail.com
About this study
This study will be a retrospective analysis of vitrectomy results in patients suffering from diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomyProcedure or surgery
Pars plana vitrectomy and ILM (internal limiting membrane) peeling
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Visual acuity will be measured using the Snellen Chart before and after vitrectomy
Measured: 6 months
Secondary outcomes (1)
Macular thickness
Macular thickness will be measured using Optical Coherence Tomography before and after vitrectomy
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 posted28 Dec 2017
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384901
- Sponsor's protocol ID
- 0109-17-HYMC
- Status last verified
- Dec 2017
- First submitted
- 20 Dec 2017
- Last updated
- 28 Dec 2017
- 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 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Results of Pars Plana Vitrectomy in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03384901
- Acronym / sponsor ID
- 0109-17-HYMC
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 28 Dec 2017 (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.
This study will be a retrospective analysis of vitrectomy results in patients suffering from diabetic macular edema.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Hillel Yaffe Medical Center Ophthalmology Clinic
Key inclusion criteria (1 listed)
- Diabetic macular edema patients after vitrectomy
Key exclusion criteria (1 listed)
- All others
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 |
|---|---|---|
| vitrectomyPars plana vitrectomy and ILM (internal limiting membrane) peeling | Procedure or surgery | – |
Primary outcome
Visual acuity
Time frame: 6 months
Visual acuity will be measured using the Snellen Chart before and after vitrectomy
1 secondary outcome
Macular thickness
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 28 Dec 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 28 Dec 2017. 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 Israel. 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 Eran Berkowitz, MD (972-54-6455753, eran.berko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (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 28 Dec 2017.