Macular HolesNCT01228188
Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes
A study testing Inverted ILM Repositioning in people with Macular Holes, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of surgical treatment of FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in patients with a macular hole. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Macular Holes
- What is being tested?
- Inverted ILM Repositioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2010to Aug 2013
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- full-thickness macular hole with a minimum diameter exceeding 400 μm
- BCVA of 0,3 or worse in log MAR units (<=70 ETDRS letter) and 1,6 or better in log MAR units (>=5 ETRDS letter)
- 18 years of age
- Informed consent
Who cannot join
- eyes with previous vitreous surgery
- cystoid macular edema from any cause
- post traumatic macular hole
- macular hole associated with retinal detachment
- any other ocular reason which causes the lack of improvement after macular hole surgery (e.g pigmentary abnormalities, age-related macular degeneration, corneal scarring)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Military Institute of Medcine
Warsaw, Ul. Szaserów 128, 04-141
Połeć Dorota, mgr, + 48 22 681 67 35, dpolec@wim.mil.pl
Robaszkiewicz Jacek, dr med.
About this study
Official title: Surgical Inverted ILM Repositioning as Autologous Dressing for Idiopathic Full Thickness Macular Holes Treatment
The purpose of this study is to evaluate the efficacy and safety of surgical treatment of FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in patients with a macular hole.
Read the detailed description
At present, the anatomical closure rate of macular hole is around 90% using pars plana vitrectomy with ILM peeling. Improvement of visual acuity is around 80% including stage II to IV. With macular hole greater than 400 μm there is higher risk of surgical failure and visual acuity is usually less than 0.2. Large macular holes are more likely to have flat-open type closure, which is anatomical success but has limited improvement in visual acuity. Inverted ILM repositioning will form a scaffold for glial cells, which allows their migration and proliferation. This process will close the macular hole and secure it from re-opening, and will reduce the risk of flat-open type of closure.
The aim of this study is to estimate the efficiency and safety of inverted ILM repositioning in the treatment of macular hole with a minimum diameter exceeding 400 μm and compare results with the currently used methods of surgical large macular holes treatment.
- Conditions
- Macular Holes
- Being tested
- Inverted ILM Repositioning
- Keywords
- FTMH, PPV, inverted ILM repositioning
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inverted ILM RepositioningProcedure or surgery
Also called inverted ILM, ILM flap
Three port pars plana vitrectomy is performed by one surgeon (JR). Induction of PVD is initiated by active suction with the vitrectomy probe over the ONH and continued peripherally. First a 0.6-1.0mm piece of ILM surrounding the macular hole is removed. Then significant margin of ILM in macular hole circumference is released while staying connected at the base to the macularrhexis border. Excess of ILM is trimmed. Perfluorocarbon is administrated, stabilizing ILM flap and facilitating the flap repositioning. Trypan Blue is used to stain the ILM. ILM flap is pressed down over the macular hole. The procedure is ended by SF6 gas tamponade. Even in absence of cataract formation, a combined procedure is performed because of exact peripheral vitreous shaving and prevention of cataract formation.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Full Thickness Macular Hole | Experimental | Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs with a minimum diameter exceeding 400 um. Receives: Procedure: Inverted ILM Repositioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Measured: up to 1 week before surgery
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Measured: 2 weeks postoperatively ( plus or minus 1 week)
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Measured: 4 weeks postoperatively ( plus or minus 1 week)
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Measured: 6 weeks postoperatively ( plus or minus 1 week)
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Measured: 12 weeks postoperatively ( plus or minus 1 week)
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Measured: 24 weeks postoperatively ( plus or minus 1 week)
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Measured: 48 weeks postoperatively ( plus or minus 1 week)
Secondary outcomes (7)
Central Macular Thickness (CMT), Central Macular Volume
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Measured: up to 1 week before surgery
Central Macular Thickness (CMT), Central Macular Volume
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Measured: 2 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Measured: 4 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Measured: 6 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Measured: 12 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Measured: 24 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Measured: 48 weeks postoperatively (plus and minus 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Jacek Robaszkiewicz, dr med., Principal investigator, Department of Ophthalmology Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228188
- Sponsor's protocol ID
- BW1127/10
- Status last verified
- Sep 2010
- First submitted
- 22 Oct 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Inverted ILM Repositioning as Autologous Dressing for Idiopathic Full Thickness Macular Holes Treatment
- ClinicalTrials.gov ID
- NCT01228188
- Acronym / sponsor ID
- BW1127/10
- Conditions
- Macular Holes
- Keywords
- FTMH, PPV, inverted ILM repositioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 26 Oct 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 evaluate the efficacy and safety of surgical treatment of FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in patients with a macular hole.
Detailed description
At present, the anatomical closure rate of macular hole is around 90% using pars plana vitrectomy with ILM peeling. Improvement of visual acuity is around 80% including stage II to IV. With macular hole greater than 400 μm there is higher risk of surgical failure and visual acuity is usually less than 0.2. Large macular holes are more likely to have flat-open type closure, which is anatomical success but has limited improvement in visual acuity. Inverted ILM repositioning will form a scaffold for glial cells, which allows their migration and proliferation. This process will close the macular hole and secure it from re-opening, and will reduce the risk of flat-open type of closure.
The aim of this study is to estimate the efficiency and safety of inverted ILM repositioning in the treatment of macular hole with a minimum diameter exceeding 400 μm and compare results with the currently used methods of surgical large macular holes treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Full Thickness Macular Hole | Experimental | Procedure: Inverted ILM RepositioningEyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs with a minimum diameter exceeding 400 um. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- full-thickness macular hole with a minimum diameter exceeding 400 μm
- BCVA of 0,3 or worse in log MAR units (<=70 ETDRS letter) and 1,6 or better in log MAR units (>=5 ETRDS letter)
- 18 years of age
- Informed consent
Key exclusion criteria (5 listed)
- eyes with previous vitreous surgery
- cystoid macular edema from any cause
- post traumatic macular hole
- macular hole associated with retinal detachment
- any other ocular reason which causes the lack of improvement after macular hole surgery (e.g pigmentary abnormalities, age-related macular degeneration, corneal scarring)
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 |
|---|---|---|
| Inverted ILM RepositioningAlso: inverted ILM, ILM flapThree port pars plana vitrectomy is performed by one surgeon (JR). Induction of PVD is initiated by active suction with the vitrectomy probe over the ONH and continued peripherally. First a 0.6-1.0mm piece of ILM surrounding the macular hole is removed. Then significant margin of ILM in macular hole circumference is released while staying connected at the base to the macularrhexis border. Excess of ILM is trimmed. Perfluorocarbon is administrated, stabilizing ILM flap and facilitating the flap repositioning. Trypan Blue is used to stain the ILM. ILM flap is pressed down over the macular hole. The procedure is ended by SF6 gas tamponade. Even in absence of cataract formation, a combined procedure is performed because of exact peripheral vitreous shaving and prevention of cataract formation. | Procedure or surgery | Idiopathic Full Thickness Macular Hole |
Primary outcome
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Time frame: up to 1 week before surgery
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Time frame: 2 weeks postoperatively ( plus or minus 1 week)
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Time frame: 4 weeks postoperatively ( plus or minus 1 week)
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Time frame: 6 weeks postoperatively ( plus or minus 1 week)
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Time frame: 12 weeks postoperatively ( plus or minus 1 week)
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Time frame: 24 weeks postoperatively ( plus or minus 1 week)
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Time frame: 48 weeks postoperatively ( plus or minus 1 week)
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
7 secondary outcomes
Central Macular Thickness (CMT), Central Macular Volume
Time frame: up to 1 week before surgery
Central Macular Thickness (CMT), Central Macular Volume
Time frame: 2 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Time frame: 4 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Time frame: 6 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Time frame: 12 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Time frame: 24 weeks postoperatively (plus and minus 1 week)
Central Macular Thickness (CMT), Central Macular Volume
Time frame: 48 weeks postoperatively (plus and minus 1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
Jacek Robaszkiewicz, dr med. principal investigator
Department of Ophthalmology Military Institute of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inverted ILM Repositioning in people with Macular Holes, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 5 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 26 Oct 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 Poland. 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 Jacek Robaszkiewicz, dr med. (+48 604597970, vectra@izet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (BCVA), postoperative macular hole closure type (time frame: up to 1 week before surgery). The study lists 7 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 26 Oct 2010.