Proliferative Diabetic RetinopathyNCT01307072
Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy
An observational study of Proliferative Diabetic Retinopathy, run by Kyorin University at 1 site in Japan.
Trial summary
The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2008to Apr 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients that underwent their first vitreous surgery for proliferaftive diabetic retinopathy
Who may be able to join
- One hundred and twenty-eight eyes of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy.
- Type 2 diabetes.
Who cannot join
- The patients were not followed more than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance to Ophthalmic Follow-up Examinations Affect Outcome of Vitrectomy for Proliferative Diabetic Retinopathy
The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.
Read the detailed description
The medical records of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy (PDR) and were followed for at least 6 months were reviewed. The subjects were divided into three groups; the never-treated group consisting of patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed; the non-compliant group consisting of patients with a history of missing ophthalmic examination over a one year period, and the compliant group consisting of patients who had ophthalmic examinations at least once a year. The evaluations included age, gender, plasma level of glycosylated hemoglobin (HbA1c) at the preoperative examination, presence of preoperative panretinal photocoagulation, preoperative best-corrected visual acuity (BCVA), postoperative BCVA at the final examination, status of the PDR, the numbers of vitreous surgeries, and presence of pre- and postoperative neovascular glaucoma.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Vitrectomy
- Keywords
- periodic examinations, compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
Also called Compliance of follow-up
Vitrectomy. Diabetic retinopathy
| Study group | Role | What they receive |
|---|---|---|
| Never-treated group | The patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed Receives: Procedure: Vitrectomy | |
| The non-compliant group | The patients with a history of missing ophthalmic examination over a one year period Receives: Procedure: Vitrectomy | |
| The compliant group | The patients who had ophthalmic examinations at least once a year Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative status
Plasma level of glycosylated hemoglobin (HbA1c)
Measured: Preoperative period
Preoperative status
Best-corrected visual acuity (BCVA),
Measured: Preoperative period
Secondary outcomes (3)
Postoperative status
Postoperative best-corrected visual acuity (BCVA) at 6 months and the final examination
Measured: up to 1 year
Postoperative status
Status of the proliferative diabetic retinopathy
Measured: up to 1 year
Postoperative status
Presence of neovascular glaucoma.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionApr 2010
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
- 94 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, Principal investigator, Kyorin Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307072
- Sponsor's protocol ID
- Kyorineye003
- Status last verified
- Jul 2012
- First submitted
- 1 Mar 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance to Ophthalmic Follow-up Examinations Affect Outcome of Vitrectomy for Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01307072
- Acronym / sponsor ID
- Kyorineye003
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- periodic examinations, compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Mar 2011 (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 relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.
Detailed description
The medical records of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy (PDR) and were followed for at least 6 months were reviewed. The subjects were divided into three groups; the never-treated group consisting of patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed; the non-compliant group consisting of patients with a history of missing ophthalmic examination over a one year period, and the compliant group consisting of patients who had ophthalmic examinations at least once a year. The evaluations included age, gender, plasma level of glycosylated hemoglobin (HbA1c) at the preoperative examination, presence of preoperative panretinal photocoagulation, preoperative best-corrected visual acuity (BCVA), postoperative BCVA at the final examination, status of the PDR, the numbers of vitreous surgeries, and presence of pre- and postoperative neovascular glaucoma.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Never-treated group | – | Procedure: VitrectomyThe patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed |
| The non-compliant group | – | Procedure: VitrectomyThe patients with a history of missing ophthalmic examination over a one year period |
| The compliant group | – | Procedure: VitrectomyThe patients who had ophthalmic examinations at least once a year |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients that underwent their first vitreous surgery for proliferaftive diabetic retinopathy
Key inclusion criteria (2 listed)
- One hundred and twenty-eight eyes of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy.
- Type 2 diabetes.
Key exclusion criteria (1 listed)
- The patients were not followed 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 |
|---|---|---|
| VitrectomyAlso: Compliance of follow-upVitrectomy. Diabetic retinopathy | Procedure or surgery | Never-treated group, The compliant group, The non-compliant group |
Primary outcome
Preoperative status
Time frame: Preoperative period
Plasma level of glycosylated hemoglobin (HbA1c)
Preoperative status
Time frame: Preoperative period
Best-corrected visual acuity (BCVA),
3 secondary outcomes
Postoperative status
Time frame: up to 1 year
Postoperative status
Time frame: up to 1 year
Postoperative status
Time frame: up to 1 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 2 Aug 2012.
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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 principal investigator
Kyorin Eye Center
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 2 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 2 Aug 2012. 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?
Preoperative status (time frame: Preoperative period). The study lists 2 primary outcomes in all. 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 2 Aug 2012.