Retinal PerforationNCT01121965
Early Vitrectomy for Impending Macular Hole
A study testing Pars plana vitrectomy with ILM peeling in people with Retinal Perforation, run by Seoul Retina Investigator Group at 10 sites in South Korea.
Trial summary
This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Retinal Perforation
- What is being tested?
- Pars plana vitrectomy with ILM peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Nov 2009to Nov 2012
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female with impending macular hole(identified with OCT)
- Age: over 45 years
- Symptom duration < 6 Months
- Visual acuity on trial: less than 73 letters in ETDRS chart Visual acuity of worsened eye: over 24 letters in ETDRS chart
Who cannot join
- Any vision disturbing disease other than impending macular hole
- Diabetic maculopathy or other retinal vascular disease
- Prior history of major trauma: If symptom begins after trauma
- Myopia over -6.5Dioper or eyes with axial length > 28mm
- Evidence of scar, degeneration or exudation of macula
- active intraocular inflammation
- History of intraocular surgery other than uncomplicated cataract extraction 3months before
- Uncontrolled IOP > 25mmHg
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Konyang University, Myung Gok Eye Research Institute
Daejeon, Daejeon, 302-718
Jong Woo Kim, M.D., 82-42-600-8816
Jong Woo Kim, M.D.
- Recruiting
HanGil Eye Hospital
Incheon, In Cheon
Joonhong Sohn, M.D., 0325033322
Joonhong Sohn, M.D.
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, 463-707
Kyu Hyung Park, M.D, 82-31-787-7373, jiani4@snu.ac.kr
Kyu Hyung Park, M.D
- Recruiting
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 82-2-3010-3673, 138-736
Young Hee Yoon, M.D., 82-2-3010-3673
Young Hee Yoon, M.D.
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 110-744
Hum Chung, M.D., 82-2-2072-2437
Hum Chung, M.D.
- Recruiting
Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
Seoul, Seoul, 134-701
Sung Pyo Park, M.D., 82-2-2224-2274
Sung Pyo Park, M.D.
- Recruiting
Samsung Medical Center
Seoul, Seoul, 135-710
Se Woong Kang, M.D., 82-2-3410-3562, swkang@skku.edu
Se Woong Kang, M.D.
- Recruiting
Catholic University of Korea
Seoul, Seoul, 137-701
Won-Ki Lee, M.D., 82-2-2258-2846
Won-Ki Lee, M.D.
- Recruiting
Gangnam Sacred Heart Hospital,Hallym University
Seoul, Seoul, 150-950
Ha Kyoung Kim, M.D., 82-2-829-5193
Ha Kyoung Kim, M.D.
- Recruiting
Kong eye clinic
Seoul, Seoul
Eun Goo Lee, M.D., 02-480-5000
Eun Goo Lee, M.D.
About this study
Official title: Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial
This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.
Read the detailed description
In a study conducted 15 years ago, the 'Vitrectomy for Prevention of Macular hole Study Group' was not able to prove the benefits and advantages of vitrectomy for impending macular hole; however, during the interim period, notable improvements have been achieved with regard to diagnosis and efficacy of treatment.
Therefore, we designed this study to identify the effect of current vitreous surgery for symptomatic impending macular hole.
Characteristics of this study is as below
- Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole occurs)
- Non-randomized study (decision was made by patients after full explanation)
- After 1 year follow up, functional change(visual acuity)and anatomical change(development of full-thickness macular hole) would be evaluated
- Conditions
- Retinal Perforation
- Being tested
- Pars plana vitrectomy with ILM peeling
- Keywords
- macular hole, impending macular hole, stage 1 macular hole
- 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 vitrectomy with ILM peelingProcedure or surgery
Also called macular hole surgery
Pars plana vitrectomy with ILM peeling
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment group | No intervention | Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs |
| Early vitrectomy | Experimental | Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur. Receives: Procedure: Pars plana vitrectomy with ILM peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual acuity
Measured: 48 weeks
Secondary outcomes (1)
Rate of occurrence of full-thickness macular hole
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2011 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal PerforationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul Retina Investigator Group
- Sponsor type
- Research network
- Investigators
- Se Woong Kang, M.D., Principal investigator, Seoul Retina Investigator Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121965
- Sponsor's protocol ID
- SRIG #1
- Status last verified
- Mar 2011
- First submitted
- 30 Apr 2010
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01121965
- Acronym / sponsor ID
- SRIG #1
- Conditions
- Retinal Perforation
- Keywords
- macular hole, impending macular hole, stage 1 macular hole
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul Retina Investigator GroupResearch network
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 12 May 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.
This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.
Detailed description
In a study conducted 15 years ago, the 'Vitrectomy for Prevention of Macular hole Study Group' was not able to prove the benefits and advantages of vitrectomy for impending macular hole; however, during the interim period, notable improvements have been achieved with regard to diagnosis and efficacy of treatment.
Therefore, we designed this study to identify the effect of current vitreous surgery for symptomatic impending macular hole.
Characteristics of this study is as below
- Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole occurs)
- Non-randomized study (decision was made by patients after full explanation)
- After 1 year follow up, functional change(visual acuity)and anatomical change(development of full-thickness macular hole) would be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment group | No intervention | –Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs |
| Early vitrectomy | Experimental | Procedure: Pars plana vitrectomy with ILM peelingPars plana vitrectomy with ILM peeling would be employed when visual symptoms occur. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female with impending macular hole(identified with OCT)
- Age: over 45 years
- Symptom duration < 6 Months
- Visual acuity on trial: less than 73 letters in ETDRS chart Visual acuity of worsened eye: over 24 letters in ETDRS chart
Key exclusion criteria (8 listed)
- Any vision disturbing disease other than impending macular hole
- Diabetic maculopathy or other retinal vascular disease
- Prior history of major trauma: If symptom begins after trauma
- Myopia over -6.5Dioper or eyes with axial length > 28mm
- Evidence of scar, degeneration or exudation of macula
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 vitrectomy with ILM peelingAlso: macular hole surgeryPars plana vitrectomy with ILM peeling | Procedure or surgery | Early vitrectomy |
Primary outcome
Best Corrected Visual acuity
Time frame: 48 weeks
1 secondary outcome
Rate of occurrence of full-thickness macular hole
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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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.
Se Woong Kang, M.D. principal investigator
Seoul Retina Investigator Group
10 sites 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 with ILM peeling in people with Retinal Perforation, run by Seoul Retina Investigator Group at 10 sites 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Se Woong Kang, M.D. (82-2-3410-3562, swkang@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual acuity (time frame: 48 weeks). 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 29 Mar 2011.