Clinical trial NCT01228188: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Holes
Keywords: FTMH
PPV
inverted ILM repositioning
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Best-corrected visual acuity (BCVA), postoperative macular hole closure type
timeFrame: up to 1 week before surgery
measure: Best-corrected visual acuity (BCVA), postoperative macular hole closure type
timeFrame: 2 weeks postoperatively ( plus or minus 1 week)
measure: Best-corrected visual acuity (BCVA), postoperative macular hole closure type
timeFrame: 4 weeks postoperatively ( plus or minus 1 week)
measure: Best-corrected visual acuity (BCVA), postoperative macular hole closure type
timeFrame: 6 weeks postoperatively ( plus or minus 1 week)
measure: Best-corrected visual acuity (BCVA), postoperative macular hole closure type
timeFrame: 12 weeks postoperatively ( plus or minus 1 week)
measure: Best-corrected visual acuity (BCVA), postoperative macular hole closure type
timeFrame: 24 weeks postoperatively ( plus or minus 1 week)
measure: Best-corrected visual acuity (BCVA), postoperative macular hole closure type
timeFrame: 48 weeks postoperatively ( plus or minus 1 week)
Secondary outcomes:
measure: Central Macular Thickness (CMT), Central Macular Volume
timeFrame: up to 1 week before surgery
measure: Central Macular Thickness (CMT), Central Macular Volume
timeFrame: 2 weeks postoperatively (plus and minus 1 week)
measure: Central Macular Thickness (CMT), Central Macular Volume
timeFrame: 4 weeks postoperatively (plus and minus 1 week)
measure: Central Macular Thickness (CMT), Central Macular Volume
timeFrame: 6 weeks postoperatively (plus and minus 1 week)
measure: Central Macular Thickness (CMT), Central Macular Volume
timeFrame: 12 weeks postoperatively (plus and minus 1 week)
measure: Central Macular Thickness (CMT), Central Macular Volume
timeFrame: 24 weeks postoperatively (plus and minus 1 week)
measure: Central Macular Thickness (CMT), Central Macular Volume
timeFrame: 48 weeks postoperatively (plus and minus 1 week)
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medcine
state: ul. Szaserów 128
Study officials:
affiliation: Department of Ophthalmology Military Institute of Medicine
name: Jacek Robaszkiewicz, dr med.
role: PRINCIPAL_INVESTIGATOR
References: