Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes
NCT ID: NCT01228188
Last Updated: 2010-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2010-08-31
2013-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Idiopathic Full Thickness Macular Hole
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.
Inverted ILM Repositioning
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.
Interventions
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Inverted ILM Repositioning
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
85 Years
ALL
No
Sponsors
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Military Institute od Medicine National Research Institute
OTHER
Responsible Party
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Military Insitute of Medicine Warsaw
Principal Investigators
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Jacek Robaszkiewicz, dr med.
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology Military Institute of Medicine
Locations
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Military Institute of Medcine
Warsaw, Ul. Szaserów 128, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BW1127/10
Identifier Type: -
Identifier Source: org_study_id