Macular Holes
Conditions
Keywords
FTMH, PPV, inverted ILM repositioning
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.
Interventions
PROCEDUREInverted 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.
Sponsors
Military Institute od Medicine National Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected visual acuity (BCVA), postoperative macular hole closure type | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Macular Thickness (CMT), Central Macular Volume | 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). |
Countries
Poland
Contacts
Primary ContactJacek Robaszkiewicz, dr med.
Backup ContactUrszula Karpińska, lek. med.
Outcome results
None listed