Diabetic Macular EdemaNCT01259609
Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy
A study testing Pars Plana Vitrectomy in people with Diabetic Macular Edema, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether ciliary body thickness increased in the presence of diabetic macular edema and whether it changed after pars plana vitrectomy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Pars Plana Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to May 2010
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic macular edema with preoperative central macular thickness > 300 μm on optical coherence tomography
- Macular edema that was not associated with an epiretinal membrane or traction membrane
- No combined traction retinal detachment or vitreous hemorrhage
- No signs of ocular inflammatory disease on preoperative examination
- Phakic eye
- An axial length between 22.0 mm and 25.0 mm
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- Non-diabetic patients with an epiretinal membrane who were scheduled for vitrectomy
- No ocular or systemic disease other than epiretinal membrane
- No diabetes
- No ocular disease other than cataract
Who cannot join
- Patients with uveitis, inflammatory connective tissue disorders or a history of previous ocular surgery
- Long-term application of topical medication, a history of intravitreal steroid or anti-VEGF injection within 3 months before vitrectomy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Seoul National University Hospital
Seoul, 110-744
About this study
The purpose of this study is to determine whether ciliary body thickness increased in the presence of diabetic macular edema and whether it changed after pars plana vitrectomy.
Read the detailed description
A diabetic macular edema group consisted of diabetic patients who underwent PPV for diffuse diabetic macular edema. A epiretinal membrane group, a surgical control group, consisted of non-diabetic patients with epiretinal membrane who underwent pars plana vitrectomy. A healthy control was also included for the comparison of preoperative ciliary body thickness. Ciliary body thickness was measured using ultrasound biomicroscopy, and central macular thickness was determined using optical coherence tomography. The visual outcome, ciliary body thickness, and central macular thickness were compared between groups before and 1, 2, and 4 months after pars plana vitrectomy and the correlations between the central macular thickness and ciliary body thickness and best corrected visual acuity were determined.
- Conditions
- Diabetic Macular Edema
- Being tested
- Pars Plana Vitrectomy
- Keywords
- Diabetic Macular Edema, Ciliary Body, Ultrasound Biomicroscopy, Vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars Plana VitrectomyProcedure or surgery
25-gauge three-port pars plana vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Macular Edema Group | Experimental | Not described Receives: Procedure: Pars Plana Vitrectomy |
| Epiretinal Membrane Group | Active comparator | Not described Receives: Procedure: Pars Plana Vitrectomy |
| Healthy Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ciliary body thickness
ciliary body thickness was determined using ultrasound biomicroscopy
Measured: up to four months after surgery
Secondary outcomes (1)
central macular thickness
central macular thickness was determined using optical coherence tomography
Measured: up to four months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startSep 2008
- Primary completionApr 2010
- Study completionMay 2010
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.
- More trials run by Seoul National 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Investigators
- Hyeong Gon Yu, M.D., Principal investigator, Department of Ophthalmology, Seoul National University Hospital, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259609
- Sponsor's protocol ID
- SNUH_OT
- Status last verified
- Dec 2010
- First submitted
- 6 Dec 2010
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy
- ClinicalTrials.gov ID
- NCT01259609
- Acronym / sponsor ID
- SNUH_OT
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, Ciliary Body, Ultrasound Biomicroscopy, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Sep 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Dec 2010 (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 purpose of this study is to determine whether ciliary body thickness increased in the presence of diabetic macular edema and whether it changed after pars plana vitrectomy.
Detailed description
A diabetic macular edema group consisted of diabetic patients who underwent PPV for diffuse diabetic macular edema. A epiretinal membrane group, a surgical control group, consisted of non-diabetic patients with epiretinal membrane who underwent pars plana vitrectomy. A healthy control was also included for the comparison of preoperative ciliary body thickness. Ciliary body thickness was measured using ultrasound biomicroscopy, and central macular thickness was determined using optical coherence tomography. The visual outcome, ciliary body thickness, and central macular thickness were compared between groups before and 1, 2, and 4 months after pars plana vitrectomy and the correlations between the central macular thickness and ciliary body thickness and best corrected visual acuity were determined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic Macular Edema Group | Experimental | Procedure: Pars Plana Vitrectomy |
| Epiretinal Membrane Group | Active comparator | Procedure: Pars Plana Vitrectomy |
| Healthy Control | No intervention | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diabetic macular edema with preoperative central macular thickness > 300 μm on optical coherence tomography
- Macular edema that was not associated with an epiretinal membrane or traction membrane
- No combined traction retinal detachment or vitreous hemorrhage
- No signs of ocular inflammatory disease on preoperative examination
- Phakic eye
Key exclusion criteria (2 listed)
- Patients with uveitis, inflammatory connective tissue disorders or a history of previous ocular surgery
- Long-term application of topical medication, a history of intravitreal steroid or anti-VEGF injection within 3 months before vitrectomy
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 Vitrectomy25-gauge three-port pars plana vitrectomy | Procedure or surgery | Diabetic Macular Edema Group, Epiretinal Membrane Group |
Primary outcome
ciliary body thickness
Time frame: up to four months after surgery
ciliary body thickness was determined using ultrasound biomicroscopy
1 secondary outcome
central macular thickness
Time frame: up to four months after surgery
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 14 Dec 2010.
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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.
Hyeong Gon Yu, M.D. principal investigator
Department of Ophthalmology, Seoul National University Hospital, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars Plana Vitrectomy in people with Diabetic Macular Edema, run by Seoul National University Hospital at 1 site in South Korea.
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 10 inclusion and 2 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 14 Dec 2010. 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 South Korea. 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?
ciliary body thickness (time frame: up to four months after surgery). 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 14 Dec 2010.