Proliferative Diabetic RetinopathyNCT01758757
Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
A study testing Vitrectomy in people with Proliferative Diabetic Retinopathy, run by Kyorin University at 1 site in Japan.
Trial summary
Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2007to Jul 2011
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients of proliferative diabetic retinopathy who underwent vitreous surgery and followed at least 6 months
Who cannot join
- The patients of proliferative diabetic retinopathy who underwent vitreous surgery but did not follow more than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.
Read the detailed description
The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous hemorrhage or progressive proliferative membrane were evaluated.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Vitrectomy
- Keywords
- Proliferative diabetic retinopathy, Vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Proliferative diabetic retinopathy | Active comparator | Not described Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of retinal breaks
Measured: One year
Secondary outcomes (1)
Incidence of neovascular glaucoma
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startSep 2007
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proliferative Diabetic RetinopathyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
- Investigators
- Makoto Inoue, MD, Study chair, Kyorin Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758757
- Sponsor's protocol ID
- Kyorineye010
- Other IDs
- Vitrectomy for PDR
- Status last verified
- Dec 2012
- First submitted
- 27 Dec 2012
- Last updated
- 1 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yokota R, Inoue M, Itoh Y, Rii T, Hirota K, Hirakata A. Comparison of microinsicion vitrectomy and conventional 20-gauge vitrectomy for severe proliferative diabetic retinopathy. Jpn J Ophthalmol. 2015 Sep;59(5):288-94. doi: 10.1007/s10384-015-0396-y. Epub 2015 Jul 23.
PubMed 26202442
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01758757
- Acronym / sponsor ID
- Kyorineye010
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative diabetic retinopathy, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Jan 2013 (estimated)
- 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.
Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.
Detailed description
The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous hemorrhage or progressive proliferative membrane were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proliferative diabetic retinopathy | Active comparator | Procedure: Vitrectomy |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patients of proliferative diabetic retinopathy who underwent vitreous surgery and followed at least 6 months
Key exclusion criteria (1 listed)
- The patients of proliferative diabetic retinopathy who underwent vitreous surgery but did not follow more than 6 months.
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 |
|---|---|---|
| Vitrectomy | Procedure or surgery | Proliferative diabetic retinopathy |
Primary outcome
Incidence of retinal breaks
Time frame: One year
1 secondary outcome
Incidence of neovascular glaucoma
Time frame: One Year
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 1 Jan 2013.
- Derived from this study: PubMed 26202442Yokota R, Inoue M, Itoh Y, Rii T, Hirota K, Hirakata A. Comparison of microinsicion vitrectomy and conventional 20-gauge vitrectomy for severe proliferative diabetic retinopathy. Jpn J Ophthalmol. 2015 Sep;59(5):288-94. doi: 10.1007/s10384-015-0396-y. Epub 2015 Jul 23.
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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.
Makoto Inoue, MD study chair
Kyorin Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy in people with Proliferative Diabetic Retinopathy, run by Kyorin University at 1 site in Japan.
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: finished, as of the sponsor's last update on 1 Jan 2013. 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 Japan. 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?
Incidence of retinal breaks (time frame: One 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 NCT01758757, which also lists 1 linked publication.
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 1 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.