Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes

Macular Holes Clinical Trial

Official title:

Surgical Inverted ILM Repositioning as Autologous Dressing for Idiopathic Full Thickness Macular Holes Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01228188
• Other study ID #: BW1127/10
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2010
• Last updated: October 25, 2010
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2010
• Source: Military Institute of Medicine, Poland
• Contact: Jacek Robaszkiewicz, dr med.
• Phone: +48 604597970
• Email: vectra[@]izet.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Inverted 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.

Locations

Country	Name	City	State
Poland	Military Institute of Medcine	Warsaw	ul. Szaserów 128

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Secondary	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).	up to 1 week before surgery	Yes
Secondary	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).	2 weeks postoperatively (plus and minus 1 week)	Yes
Secondary	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).	4 weeks postoperatively (plus and minus 1 week)	Yes
Secondary	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).	6 weeks postoperatively (plus and minus 1 week)	Yes
Secondary	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).	12 weeks postoperatively (plus and minus 1 week)	Yes
Secondary	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).	24 weeks postoperatively (plus and minus 1 week)	Yes
Secondary	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).	48 weeks postoperatively (plus and minus 1 week)	Yes