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Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Military Institute of Medicine, Poland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier:
NCT01228188
First received: October 22, 2010
Last updated: October 25, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Macular Holes
Procedure: Inverted ILM Repositioning

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Inverted ILM Repositioning as Autologous Dressing for Idiopathic Full Thickness Macular Holes Treatment

Further study details as provided by Military Institute of Medicine, Poland:

Primary Outcome Measures:
  • Best-corrected visual acuity (BCVA), postoperative macular hole closure type [ Time Frame: up to 1 week before surgery ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.


Secondary Outcome Measures:
  • Central Macular Thickness (CMT), Central Macular Volume [ Time Frame: up to 1 week before surgery ] [ Designated as safety issue: Yes ]
    Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).

  • Central Macular Thickness (CMT), Central Macular Volume [ Time Frame: 2 weeks postoperatively (plus and minus 1 week) ] [ Designated as safety issue: Yes ]
    Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).

  • Central Macular Thickness (CMT), Central Macular Volume [ Time Frame: 4 weeks postoperatively (plus and minus 1 week) ] [ Designated as safety issue: Yes ]
    Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).

  • Central Macular Thickness (CMT), Central Macular Volume [ Time Frame: 6 weeks postoperatively (plus and minus 1 week) ] [ Designated as safety issue: Yes ]
    Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).

  • Central Macular Thickness (CMT), Central Macular Volume [ Time Frame: 12 weeks postoperatively (plus and minus 1 week) ] [ Designated as safety issue: Yes ]
    Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).

  • Central Macular Thickness (CMT), Central Macular Volume [ Time Frame: 24 weeks postoperatively (plus and minus 1 week) ] [ Designated as safety issue: Yes ]
    Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).

  • Central Macular Thickness (CMT), Central Macular Volume [ Time Frame: 48 weeks postoperatively (plus and minus 1 week) ] [ Designated as safety issue: Yes ]
    Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).


Estimated Enrollment: 25
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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 Names:
  • inverted ILM
  • ILM flap

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228188

Contacts
Contact: Jacek Robaszkiewicz, dr med. +48 604597970 vectra@izet.pl
Contact: Urszula Karpińska, lek. med. +48 668335961 bequille@gmail.com

Locations
Poland
Military Institute of Medcine Recruiting
Warsaw, ul. Szaserów 128, Poland, 04-141
Contact: Połeć Dorota, mgr    + 48 22 681 67 35    dpolec@wim.mil.pl   
Principal Investigator: Robaszkiewicz Jacek, dr med.         
Sub-Investigator: Chmielewska I. Katarzyna, lek. med.         
Sub-Investigator: Karpińska Urszula, lek. med.         
Sponsors and Collaborators
Military Institute of Medicine, Poland
Investigators
Principal Investigator: Jacek Robaszkiewicz, dr med. Department of Ophthalmology Military Institute of Medicine
  More Information

No publications provided

Responsible Party: Department of Ophthalmology, Military Insitute of Medicine Warsaw
ClinicalTrials.gov Identifier: NCT01228188     History of Changes
Other Study ID Numbers: BW1127/10
Study First Received: October 22, 2010
Last Updated: October 25, 2010
Health Authority: Poland: Ethics Committee

Keywords provided by Military Institute of Medicine, Poland:
FTMH
PPV
inverted ILM repositioning

Additional relevant MeSH terms:
Retinal Perforations
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on November 19, 2014