Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison

Macular Holes Clinical Trial

Official title:

Comparing Retinal Sensitivity and Fixation Stability of Inverted ILM-flap Techniques Variants for Macular Hole Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135638
• Other study ID #: 14738
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: October 2019
• Source: University of Molise
• Contact: Ciro Costagliola, MD
• Phone: +390874404448
• Email: ciro.costagliola[@]unimol.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To report closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.

Description:

Patients will be randomized (1:1) to receive a vitrectomy with either Cover or Fill ILM flap technique. "Cover" when the ILM flap is everted over the MH gap in a single layer, "Fill" when the ILM is folded into multiple layers within the MH. All patients will undergo BCVA, RS and FS assessment at baseline, 1-month and 3-months after surgery.

Purpose of the study is to report retinal differential sensitivity and fixation stability as well as anatomic and visual outcomes of patients operated on for idiopathic MH and randomly assigned to Fill or Cover Groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: April 10, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with idiopatic macular holes

Exclusion Criteria:

• Patients with MH duration greater than 6 months

• myopia exceeding 6 diopters

• history of trauma

• previous ocular surgery except uncomplicated cataract extraction with in-the-bag IOL implantation

• any ocular illness including glaucoma, uveitis, optic nerve pathology

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Cover Group
"Cover" when the ILM flap is everted over the MH gap in a single layer
• Fill Group
"Fill" when the ILM is folded into multiple layers within the MH

Locations

Country	Name	City	State
Italy	University of Molise	Campobasso

Sponsors (4)

Lead Sponsor	Collaborator
University of Molise	Fondazione G.B. Bietti, IRCCS, Ospedale Policlinico San Martino, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Country where clinical trial is conducted

Italy, 

References & Publications (12)

Aurora A, Seth A, Sanduja N. Cabbage Leaf Inverted Flap ILM Peeling for Macular Hole: A Novel Technique. Ophthalmic Surg Lasers Imaging Retina. 2017 Oct 1;48(10):830-832. doi: 10.3928/23258160-20170928-08. — View Citation

Bonnabel A, Bron AM, Isaico R, Dugas B, Nicot F, Creuzot-Garcher C. Long-term anatomical and functional outcomes of idiopathic macular hole surgery. The yield of spectral-domain OCT combined with microperimetry. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2505-11. doi: 10.1007/s00417-013-2339-y. Epub 2013 Apr 26. — View Citation

Chen SN. Large semicircular inverted internal limiting membrane flap in the treatment of macular hole in high myopia. Graefes Arch Clin Exp Ophthalmol. 2017 Dec;255(12):2337-2345. doi: 10.1007/s00417-017-3808-5. Epub 2017 Oct 10. — View Citation

Chen WC, Wang Y, Li XX. Morphologic and functional evaluation before and after successful macular hole surgery using spectral-domain optical coherence tomography combined with microperimetry. Retina. 2012 Oct;32(9):1733-42. — View Citation

Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. — View Citation

Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11. — View Citation

Molina-Martín A, Pérez-Cambrodí RJ, Piñero DP. Current Clinical Application of Microperimetry: A Review. Semin Ophthalmol. 2018;33(5):620-628. doi: 10.1080/08820538.2017.1375125. Epub 2017 Oct 9. Review. — View Citation

Rizzo S, Tartaro R, Barca F, Caporossi T, Bacherini D, Giansanti F. INTERNAL LIMITING MEMBRANE PEELING VERSUS INVERTED FLAP TECHNIQUE FOR TREATMENT OF FULL-THICKNESS MACULAR HOLES: A COMPARATIVE STUDY IN A LARGE SERIES OF PATIENTS. Retina. 2018 Sep;38 Suppl 1:S73-S78. doi: 10.1097/IAE.0000000000001985. — View Citation

Rossi T, Gelso A, Costagliola C, Trillo C, Costa A, Gesualdo C, Ripandelli G. Macular hole closure patterns associated with different internal limiting membrane flap techniques. Graefes Arch Clin Exp Ophthalmol. 2017 Jun;255(6):1073-1078. doi: 10.1007/s00417-017-3598-9. Epub 2017 Feb 4. — View Citation

Sun Z, Gan D, Jiang C, Wang M, Sprecher A, Jiang AC, Xu G. Effect of preoperative retinal sensitivity and fixation on long-term prognosis for idiopathic macular holes. Graefes Arch Clin Exp Ophthalmol. 2012 Nov;250(11):1587-96. doi: 10.1007/s00417-012-1997-5. Epub 2012 Mar 24. — View Citation

Tarita-Nistor L, González EG, Mandelcorn MS, Lillakas L, Steinbach MJ. Fixation stability, fixation location, and visual acuity after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):84-9. doi: 10.1167/iovs.08-2342. Epub 2008 Aug 29. — View Citation

Wang Z, Qi Y, Liang X, Yu Y, Chen J, Wang J, Liu X, Liu W. MP-3 measurement of retinal sensitivity in macular hole area and its predictive value on visual prognosis. Int Ophthalmol. 2019 Sep;39(9):1987-1994. doi: 10.1007/s10792-018-1032-x. Epub 2018 Oct 3. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual outcome linked to "Cover" and "Fill" procedures	To report : - Best Corrected Visual Acuity (BCVA expressed in logMAR); of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.	five months
Primary	Anatomical outcome linked to "Cover" and "Fill" procedures	To report: - closure rate (µm); of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure	five months
Secondary	Macular sensitivity linked to "Cover" and "Fill" procedures	To report: Retinal Sensitivity (RS expressed in dB); Fixation Stability (FS expressed as: 0 = stable, 1 = relatively (stable,2 = unstable); of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.	five months