Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

October 25, 2010 updated by: Military Institute of Medicine, Poland

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.

Study Overview

Status

Unknown

Conditions

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jacek Robaszkiewicz, dr med.
  • Phone Number: +48 604597970
  • Email: vectra@izet.pl

Study Contact Backup

  • Name: Urszula Karpińska, lek. med.
  • Phone Number: +48 668335961
  • Email: bequille@gmail.com

Study Locations

    • ul. Szaserów 128
      • Warsaw, ul. Szaserów 128, Poland, 04-141
        • Recruiting
        • Military Institute of Medcine
        • Contact:
        • Principal Investigator:
          • Robaszkiewicz Jacek, dr med.
        • Sub-Investigator:
          • Chmielewska I. Katarzyna, lek. med.
        • Sub-Investigator:
          • Karpińska Urszula, lek. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 week before surgery
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.
2 weeks postoperatively ( plus or minus 1 week)
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.
4 weeks postoperatively ( plus or minus 1 week)
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.
6 weeks postoperatively ( plus or minus 1 week)
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.
12 weeks postoperatively ( plus or minus 1 week)
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.
24 weeks postoperatively ( plus or minus 1 week)
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.
48 weeks postoperatively ( plus or minus 1 week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Macular Thickness (CMT), Central Macular Volume
Time Frame: up to 1 week before surgery
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
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)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
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)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
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)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
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)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
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)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
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)
Central Macular Thickness (CMT)and Central Macular Volume are assessed 1 mm and 6 mm diameter topography (OCT-SLO).
48 weeks postoperatively (plus and minus 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jacek Robaszkiewicz, dr med., Department of Ophthalmology Military Institute of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 26, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2010

Last Update Submitted That Met QC Criteria

October 25, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BW1127/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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