Proliferative Diabetic RetinopathyNCT03525899
Macular Hole After Diabetic Vitrectomy
An observational study of Proliferative Diabetic Retinopathy and Macular Holes, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To present the clinical characteristics and rational treatment of macular hole (MH) after the diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Macular Holes
- What is being tested?
- Pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2017to 1 Dec 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from January 2010 to May 2017 treated by a single surgeon (Y.C.M) at National Taiwan University Hospital were retrospectively reviewed.
Who may be able to join
- Proliferative diabetic retinopathy patients presenting with macular hole after primary diabetic vitrectomy
- The persistent MH group after surgery, who had MH before the primary DV
- Newly-developed MH group, who developed MH after a successful primary diabetic retinopathy
Who cannot join
- Patients with peripheral breaks
- Patients with macular hole before surgery, which closed after primary diabetic retinopathy
- Missing clinical data
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Ophthalmology, National Taiwan University Hospital
Taipei, 100
About this study
To present the clinical characteristics and rational treatment of macular hole (MH) after the diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR).
Read the detailed description
All patients had received initial vitrectomy to treat complications of PDR. Recruited patients were divided to two groups: the persistent MH group, who had MH before the primary DV (group 1); and the newly-developed MH group, who developed MH after a successful primary DV (group 2). The patients' demographic data, records of ophthalmological examinations, and surgical procedures were collected, including best-corrected visual acuity before and after each operation, fundus changes, as well as MH repairing techniques. The extent of fibrovascular proliferation(FVP) was separated into four grades based on the severity of vitreoretinal adhesion : multiple-point adhesions with or without one site plaque-like broad adhesion (grade 1), broad adhesions in more than one but fewer than three sites, located posterior to the equator (grade 2), broad adhesions in more than three sites, located posterior to the equator or extending beyond the equator within one quadrant (grade 3), and broad adhesions extending beyond the equator for more than one quadrant (grade 4). The extent of retinal detachment (RD) was classified into "within the arcade" or "beyond the arcade". The macular structure was evaluated by optical coherence tomography (OCT). All patients had a follow-up duration of more than three months after the final surgical procedures.
Three different surgical techniques were used to treat MH: standard internal limiting membrane (ILM) peeling, inverted ILM flap insertion into the MH, and lens anterior or posterior capsular flap insertion into the MH. The indication(s) for each technique were:
standard ILM peeling was performed if no ILM peeling had been done in the previous surgery, and the MH size was less than 500um in an attached retina; inverted ILM flap insertion was performed if no ILM peeling had been done in the previous surgery, with a detached retina; lens anterior capsule flap insertion was performed if cataract surgery was performed in the same setting with no ILM tissue available; lens posterior capsule flap insertion was performed in a pseudophakic eye with no ILM tissue available. Only descriptive statistics was obtained.
- Conditions
- Proliferative Diabetic Retinopathy, Macular Holes
- Being tested
- Pars plana vitrectomy
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomyProcedure or surgery
Pars plana vitrectomy combined with Internal limiting membrane peeling, inverted internal limiting membrane flap insertion into the macular hole, or lens anterior or posterior capsular flap insertion into the macular hole
| Study group | Role | What they receive |
|---|---|---|
| MH after diabetic pars plana vitrectomy | Recruited patients included, the persistent MH group, who had MH before the primary DV, and the newly-developed MH group, who developed MH after a successful primary DV Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to macular hole closure
Evaluation by optical coherence tomography
Measured: OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year
Secondary outcomes (1)
Best corrected visual acuity
Landolt C chart
Measured: One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Nov 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung-May Yang, MD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525899
- Sponsor's protocol ID
- 201709039RINB
- Status last verified
- Oct 2017
- First submitted
- 8 Apr 2018
- Last updated
- 16 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yeh PT, Cheng CK, Chen MS, Yang CH, Yang CM. Macular hole in proliferative diabetic retinopathy with fibrovascular proliferation. Retina. 2009 Mar;29(3):355-61. doi: 10.1097/IAE.0b013e31818c3251.
PubMed 18997639Chen SN, Yang CM. LENS CAPSULAR FLAP TRANSPLANTATION IN THE MANAGEMENT OF REFRACTORY MACULAR HOLE FROM MULTIPLE ETIOLOGIES. Retina. 2016 Jan;36(1):163-70. doi: 10.1097/IAE.0000000000000674.
PubMed 26200509Ghoraba H. Types of macular holes encountered during diabetic vitrectomy. Retina. 2002 Apr;22(2):176-82. doi: 10.1097/00006982-200204000-00007.
PubMed 11927850
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Hole After Diabetic Vitrectomy
- ClinicalTrials.gov ID
- NCT03525899
- Acronym / sponsor ID
- 201709039RINB
- Conditions
- Proliferative Diabetic Retinopathy, Macular Holes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 16 May 2018 (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.
To present the clinical characteristics and rational treatment of macular hole (MH) after the diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR).
Detailed description
All patients had received initial vitrectomy to treat complications of PDR. Recruited patients were divided to two groups: the persistent MH group, who had MH before the primary DV (group 1); and the newly-developed MH group, who developed MH after a successful primary DV (group 2). The patients' demographic data, records of ophthalmological examinations, and surgical procedures were collected, including best-corrected visual acuity before and after each operation, fundus changes, as well as MH repairing techniques. The extent of fibrovascular proliferation(FVP) was separated into four grades based on the severity of vitreoretinal adhesion : multiple-point adhesions with or without one site plaque-like broad adhesion (grade 1), broad adhesions in more than one but fewer than three sites, located posterior to the equator (grade 2), broad adhesions in more than three sites, located posterior to the equator or extending beyond the equator within one quadrant (grade 3), and broad adhesions extending beyond the equator for more than one quadrant (grade 4). The extent of retinal detachment (RD) was classified into "within the arcade" or "beyond the arcade". The macular structure was evaluated by optical coherence tomography (OCT). All patients had a follow-up duration of more than three months after the final surgical procedures.
Three different surgical techniques were used to treat MH: standard internal limiting membrane (ILM) peeling, inverted ILM flap insertion into the MH, and lens anterior or posterior capsular flap insertion into the MH. The indication(s) for each technique were:
standard ILM peeling was performed if no ILM peeling had been done in the previous surgery, and the MH size was less than 500um in an attached retina; inverted ILM flap insertion was performed if no ILM peeling had been done in the previous surgery, with a detached retina; lens anterior capsule flap insertion was performed if cataract surgery was performed in the same setting with no ILM tissue available; lens posterior capsule flap insertion was performed in a pseudophakic eye with no ILM tissue available. Only descriptive statistics was obtained.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MH after diabetic pars plana vitrectomy | – | Procedure: Pars plana vitrectomyRecruited patients included, the persistent MH group, who had MH before the primary DV, and the newly-developed MH group, who developed MH after a successful primary DV |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from January 2010 to May 2017 treated by a single surgeon (Y.C.M) at National Taiwan University Hospital were retrospectively reviewed.
Key inclusion criteria (3 listed)
- Proliferative diabetic retinopathy patients presenting with macular hole after primary diabetic vitrectomy
- The persistent MH group after surgery, who had MH before the primary DV
- Newly-developed MH group, who developed MH after a successful primary diabetic retinopathy
Key exclusion criteria (3 listed)
- Patients with peripheral breaks
- Patients with macular hole before surgery, which closed after primary diabetic retinopathy
- Missing clinical data
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 |
|---|---|---|
| Pars plana vitrectomyPars plana vitrectomy combined with Internal limiting membrane peeling, inverted internal limiting membrane flap insertion into the macular hole, or lens anterior or posterior capsular flap insertion into the macular hole | Procedure or surgery | MH after diabetic pars plana vitrectomy |
Primary outcome
Time to macular hole closure
Time frame: OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year
Evaluation by optical coherence tomography
1 secondary outcome
Best corrected visual acuity
Time frame: One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.
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 16 May 2018.
- Background: PubMed 18997639Yeh PT, Cheng CK, Chen MS, Yang CH, Yang CM. Macular hole in proliferative diabetic retinopathy with fibrovascular proliferation. Retina. 2009 Mar;29(3):355-61. doi: 10.1097/IAE.0b013e31818c3251.
- Background: PubMed 26200509Chen SN, Yang CM. LENS CAPSULAR FLAP TRANSPLANTATION IN THE MANAGEMENT OF REFRACTORY MACULAR HOLE FROM MULTIPLE ETIOLOGIES. Retina. 2016 Jan;36(1):163-70. doi: 10.1097/IAE.0000000000000674.
- Background: PubMed 11927850Ghoraba H. Types of macular holes encountered during diabetic vitrectomy. Retina. 2002 Apr;22(2):176-82. doi: 10.1097/00006982-200204000-00007.
- Individual participant dataSharing planned: Undecided
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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.
Chung-May Yang, MD study director
National Taiwan University Hospital
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 Proliferative Diabetic Retinopathy and Macular Holes, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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 16 May 2018. 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 Taiwan. 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?
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?
Time to macular hole closure (time frame: OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03525899, which also lists 3 linked publications.
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 16 May 2018.