Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes - Full Text View

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

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

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
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013