Proliferative Diabetic RetinopathyNCT02464800
Efficacy of Higher Cutting Rate in Microincision Vitrectomy for Proliferative Diabetic Retinopathy
An observational study of Proliferative Diabetic Retinopathy, run by Kyorin University at 1 site in Japan.
Trial summary
The medical records of 393 eyes of 326 patients with severe proliferative diabetic retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in 174 eyes and conventional instruments in 219 eyes (2500 cut per minute). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Vitrectomy for proliferative diabetic retinopathy
- Type of treatment
- Surgery or procedure
- How many people
- 326 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Mar 2015
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who underwent 25-gauge vitrectomy for proliferative diabetic retinopathy with higher cutting rate instruments or conventional instruments
Who may be able to join
- The inclusion criteria were patients who had persistent vitreous hemorrhage, fibrovascular proliferation affecting the macula, or tractional RD and who had a follow-up for more than 6 months.
Who cannot join
- The eyes with follow-up less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The medical records of 393 eyes of 326 patients with severe proliferative diabetic retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in 174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome and incidences of intraoperative and postoperative complications were compared.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Vitrectomy for proliferative diabetic retinopathy
- Keywords
- diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy for proliferative diabetic retinopathyProcedure or surgery
25-gauge vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Higher cutting rate group | Vitrectomy with higher cutting rate instruments (5000 cut per minute) were performed in 174 eyes for proliferative diabetic retinopathy Receives: Procedure: Vitrectomy for proliferative diabetic retinopathy | |
| Conventional cutting rate group | Vitrectomy with conventional instruments (2500 cut per minute) were performed in 219 eyes for proliferative diabetic retinopathy Receives: Procedure: Vitrectomy for proliferative diabetic retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 6 months
Secondary outcomes (1)
Retinal reattachment
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 Jun 2015 (estimated)
- Study startApr 2007
- Primary completionMar 2014
- Study completionMar 2015
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.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464800
- Sponsor's protocol ID
- Kyorineye016
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2015
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Higher Cutting Rate in Microincision Vitrectomy for Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT02464800
- Acronym / sponsor ID
- Kyorineye016
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Jun 2015 (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.
The medical records of 393 eyes of 326 patients with severe proliferative diabetic retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in 174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome and incidences of intraoperative and postoperative complications were compared.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher cutting rate group | – | Procedure: Vitrectomy for proliferative diabetic retinopathyVitrectomy with higher cutting rate instruments (5000 cut per minute) were performed in 174 eyes for proliferative diabetic retinopathy |
| Conventional cutting rate group | – | Procedure: Vitrectomy for proliferative diabetic retinopathyVitrectomy with conventional instruments (2500 cut per minute) were performed in 219 eyes for proliferative diabetic retinopathy |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who underwent 25-gauge vitrectomy for proliferative diabetic retinopathy with higher cutting rate instruments or conventional instruments
Key inclusion criteria (1 listed)
- The inclusion criteria were patients who had persistent vitreous hemorrhage, fibrovascular proliferation affecting the macula, or tractional RD and who had a follow-up for more than 6 months.
Key exclusion criteria (1 listed)
- The eyes with follow-up less 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 for proliferative diabetic retinopathy25-gauge vitrectomy | Procedure or surgery | Conventional cutting rate group, Higher cutting rate group |
Primary outcome
Visual acuity
Time frame: 6 months
1 secondary outcome
Retinal reattachment
Time frame: 6 months
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 8 Jun 2015.
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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.
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, 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 8 Jun 2015. 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?
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 8 Jun 2015.