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Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

Primary Purpose

Macular Holes

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Inverted ILM Repositioning
Sponsored by
Military Institute od Medicine National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes focused on measuring FTMH, PPV, inverted ILM repositioning

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Military Institute of MedcineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Idiopathic Full Thickness Macular Hole

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
October 22, 2010
Last Updated
October 25, 2010
Sponsor
Military Institute od Medicine National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01228188
Brief Title
Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes
Official Title
Surgical Inverted ILM Repositioning as Autologous Dressing for Idiopathic Full Thickness Macular Holes Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Military Institute od Medicine National Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
FTMH, PPV, inverted ILM repositioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Idiopathic Full Thickness Macular Hole
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Inverted ILM Repositioning
Other Intervention Name(s)
inverted ILM, ILM flap
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Description
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Time Frame
up to 1 week before surgery
Title
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Description
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Time Frame
2 weeks postoperatively ( plus or minus 1 week)
Title
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Description
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Time Frame
4 weeks postoperatively ( plus or minus 1 week)
Title
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Description
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Time Frame
6 weeks postoperatively ( plus or minus 1 week)
Title
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Description
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Time Frame
12 weeks postoperatively ( plus or minus 1 week)
Title
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Description
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Time Frame
24 weeks postoperatively ( plus or minus 1 week)
Title
Best-corrected visual acuity (BCVA), postoperative macular hole closure type
Description
BCVA for ETDRS chart (converted to logMAR) and postoperative macular hole closure type assessed by OCT: elevated-open, flat-open and flat-closed.
Time Frame
48 weeks postoperatively ( plus or minus 1 week)
Secondary Outcome Measure Information:
Title
Central Macular Thickness (CMT), Central Macular Volume
Description
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Time Frame
up to 1 week before surgery
Title
Central Macular Thickness (CMT), Central Macular Volume
Description
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Time Frame
2 weeks postoperatively (plus and minus 1 week)
Title
Central Macular Thickness (CMT), Central Macular Volume
Description
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Time Frame
4 weeks postoperatively (plus and minus 1 week)
Title
Central Macular Thickness (CMT), Central Macular Volume
Description
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Time Frame
6 weeks postoperatively (plus and minus 1 week)
Title
Central Macular Thickness (CMT), Central Macular Volume
Description
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Time Frame
12 weeks postoperatively (plus and minus 1 week)
Title
Central Macular Thickness (CMT), Central Macular Volume
Description
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Time Frame
24 weeks postoperatively (plus and minus 1 week)
Title
Central Macular Thickness (CMT), Central Macular Volume
Description
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
Time Frame
48 weeks postoperatively (plus and minus 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacek Robaszkiewicz, dr med.
Phone
+48 604597970
Email
vectra@izet.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Urszula Karpińska, lek. med.
Phone
+48 668335961
Email
bequille@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Robaszkiewicz, dr med.
Organizational Affiliation
Department of Ophthalmology Military Institute of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military Institute of Medcine
City
Warsaw
State/Province
ul. Szaserów 128
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Połeć Dorota, mgr
Phone
+ 48 22 681 67 35
Email
dpolec@wim.mil.pl
First Name & Middle Initial & Last Name & Degree
Robaszkiewicz Jacek, dr med.
First Name & Middle Initial & Last Name & Degree
Chmielewska I. Katarzyna, lek. med.
First Name & Middle Initial & Last Name & Degree
Karpińska Urszula, lek. med.

12. IPD Sharing Statement

Learn more about this trial

Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

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