NCT01228188

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 26, 2010

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

October 22, 2010

Last Update Submit

October 25, 2010

Conditions

Macular Holes

Keywords

FTMHPPVinverted ILM repositioning

Outcome Measures

Primary Outcomes (7)

  • 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.

    up to 1 week before surgery

  • 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.

    2 weeks postoperatively ( plus or minus 1 week)

  • 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.

    4 weeks postoperatively ( plus or minus 1 week)

  • 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.

    6 weeks postoperatively ( plus or minus 1 week)

  • 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.

    12 weeks postoperatively ( plus or minus 1 week)

  • 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.

    24 weeks postoperatively ( plus or minus 1 week)

  • 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.

    48 weeks postoperatively ( plus or minus 1 week)

Secondary Outcomes (7)

  • Central Macular Thickness (CMT), Central Macular Volume

    up to 1 week before surgery

  • Central Macular Thickness (CMT), Central Macular Volume

    2 weeks postoperatively (plus and minus 1 week)

  • Central Macular Thickness (CMT), Central Macular Volume

    4 weeks postoperatively (plus and minus 1 week)

  • Central Macular Thickness (CMT), Central Macular Volume

    6 weeks postoperatively (plus and minus 1 week)

  • Central Macular Thickness (CMT), Central Macular Volume

    12 weeks postoperatively (plus and minus 1 week)

  • +2 more secondary outcomes

Study Arms (1)

Idiopathic Full Thickness Macular Hole

EXPERIMENTAL

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

Interventions

Inverted ILM RepositioningPROCEDURE

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.

Also known as: inverted ILM, ILM flap
Idiopathic Full Thickness Macular Hole

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • years of age
  • Informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Medcine

Warsaw, Ul. Szaserów 128, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Jacek Robaszkiewicz, dr med.

    Department of Ophthalmology Military Institute of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacek Robaszkiewicz, dr med.

CONTACT

+48 604597970vectra@izet.pl

Urszula Karpińska, lek. med.

CONTACT

+48 668335961bequille@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 26, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2013

Last Updated

October 26, 2010

Record last verified: 2010-09

Locations

PL(1)