Inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment in high myopia: study protocol for a randomized controlled clinical trial

Ying Zheng, Mei Kang, Hong Wang, Haiyun Liu, Tao Sun, Xiaodong Sun, Fenghua Wang, Ying Zheng, Mei Kang, Hong Wang, Haiyun Liu, Tao Sun, Xiaodong Sun, Fenghua Wang

Abstract

Background: Macular hole retinal detachment (MHRD) occurs most commonly in high myopia and causes severe visual impairment and greatly reduces the quality of life. The aim of this study is to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also to compare the treatment efficacy with that of the conventional "vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade" method for high myopia-associated MHRD.

Methods/design: In this clinical trial, 38 patients with MHRD in high myopia will be randomly assigned to two groups (Group 1: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus air-fluid exchange plus silicone oil infusion; Group 2: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus inverted internal limiting membrane insertion plus air-fluid exchange). The primary outcome is macular hole closure rate in 3 months after the initial surgery. The secondary outcomes are best corrected visual acuity (BCVA), reattachment rate of retinal detachment, and postoperative complication rate.

Discussion: The study results may help to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also compare the efficacy of the new treatment with the conventional "vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade" method. This trial may provide a novel surgical treatment for MHRD in high myopia with more effectiveness and less pain.

Trial registration: ClinicalTrials.gov, NCT03383731 . Registered on 19 December 2017. Retrospectively registered.

Keywords: Air tamponade; High myopia; Inverted internal limiting membrane insertion; Macular hole retinal detachment.

Conflict of interest statement

Ethics approval and consent to participate

The ethics committee of the Shanghai General Hospital Institutional Review Board has granted ethics approval for this study (6 April 2017, Approval Number: 2017 [16]). Written informed consent will be obtained from all participants or their authorized representatives.

Consent for publication

Not applicable. Results will be presented at relevant national and international conferences as well as being published in peer-reviewed journals.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design

References

    1. Morita H, Ideta H, Ito K, et al. Causative factors of retinal detachment in macular holes. Retina. 1991;11:281–284. doi: 10.1097/00006982-199111030-00002.
    1. Elina O, Teresio A, Vincenza B. Surgical management of retinal detachment because of macular hole in highly myopic eyes. Retina. 2012;32:1704–1718. doi: 10.1097/IAE.0b013e31826b671c.
    1. Feman SS, Hepler RS, Straatsma BR. Rhegmatogenous retinal detachment due to macular hole. Management with cryotherapy and a Y-shaped sling. Arch Ophthalmol. 1974;91:371–372. doi: 10.1001/archopht.1974.03900060383007.
    1. Li MF. Chinese ophthalmology[M] Beijing: People’s Medical Publishing House; 2014. pp. 2363–2364.
    1. Hong MC, Wu TT, Sheu SJ. Primary gas tamponade in the management of retinal detachment in highly myopic eyes with macular hole. J Chin Med Assoc. 2011;74:121–124. doi: 10.1016/j.jcma.2011.01.026.
    1. Miyake Y. A simplified method of treating retinal detachment with macular hole. Am J Ophthalmol. 1984;97:243–245. doi: 10.1016/S0002-9394(14)76099-4.
    1. Mete M, Parolini B, Maggio E, et al. 1000 cSt silicone oil vs heavy silicone oil as intraocular tamponade in retinal detachment associated to myopic macular hole. Graefes Arch Clin Exp Ophtalmol. 2011;249:821–826. doi: 10.1007/s00417-010-1557-9.
    1. Soheilian M, Ghaseminejad AK, Yazdani S, et al. Surgical management of retinal detachment in highly myopic eyes with macular hole. Ophthalmic Surg Lasers Imaging. 2007;38:15–22.
    1. Li XX, Wang WJ, Tang SB, et al. Gas injection versus vitrectomy with gas for treating retinal detachment owing to macular hole in high myopes. Ophthalmology. 2009;116:1182–1187. doi: 10.1016/j.ophtha.2009.01.003.
    1. Uemoto R, Yamamoto S, Tsukahara I, Takeuchi S. Efficacy of internal limiting membrane removal for retinal detachments resulting from a myopic macular hole. Retina. 2004;24(4):560–566. doi: 10.1097/00006982-200408000-00009.
    1. Lim LS, Tsai A, Wong D, et al. Prognostic factor analysis of vitrectomy for retinal detachment associated with myopic macular hole. Ophthalmology. 2014;121(1):305–310. doi: 10.1016/j.ophtha.2013.08.033.
    1. Matsumura T, Takamura Y, Tomomatsu T, et al. Comparison of the inverted internal limiting membrane flap technique and the internal limiting membrane peeling for macular hole with retinal detachment. PLoS One. 2016;11:e0165068. doi: 10.1371/journal.pone.0165068.
    1. Baba R, Wakabayashi Y, Umazume K, et al. Efficacy of the inverted internal limiting membrane flap technique with vitrectomy for retinal detachment associated with myopic macular holes. Retina. 2017;37:466–471. doi: 10.1097/IAE.0000000000001211.
    1. Ichibe M, Yoshizawa T, Murakami K, et al. Surgical management of retinal detachment associated with myopic macular hole: anatomic and functional status of the macula. Am J Ophthalmol. 2003;136:277–284. doi: 10.1016/S0002-9394(03)00186-7.
    1. Oie Y, Emi K, Takaoka G, Ikeda T. Effect of indocyanine green staining in peeling of internal limiting membrane for retinal detachment resulting from macular hole in myopic eyes. Ophthalmology. 2007;114:303–306. doi: 10.1016/j.ophtha.2006.07.052.
    1. Takahashi H, Inoue M, Koto T, et al. Inverted internal limiting membrane flap technique for treatment of macular hole retinal detachment in highly myopic eyes. Retina. 2017;0:1–20. doi: 10.1097/IAE.0000000000001898.
    1. Shin MK, Park KH, Park SW, et al. Perfluoro-n-octane-assisted single-layered inverted internal limiting membrane flap technique for macular hole surgery. Retina. 2014;34(9):1905–1910. doi: 10.1097/IAE.0000000000000339.
    1. Michalewska Z, Michalewski J, Dulczewska-Cichecka, et al. Temporal inverted internal limiting membrane flap technique versus classic inverted internal limiting membrane flap technique: a comparative study. Retina. 2015;35(9):1844–1850. doi: 10.1097/IAE.0000000000000555.
    1. Kuriyama S. Efficacy of inverted internal limiting membrane flap technique for the treatment of macular hole in high myopia. Am J Ophthalmol. 2013;156(1):125–131. doi: 10.1016/j.ajo.2013.02.014.
    1. Hasegawa Y, Hata Y, Mochizuki Y, et al. Equivalent tamponade by room air as compared with SF6 macular hole surgery. Graefes Arch Clin Exp Ophthalmol. 2009;247(11):1455–1459. doi: 10.1007/s00417-009-1120-8.
    1. He F, Dong F, Yu W, Dai R. Recovery of photoreceptor layer on spectral-domain optical coherence tomography after vitreous surgery combined with air tamponade in chronic idiopathic macular hole. Ophthalmic Surg Lasers Imaging Retina. 2015;46(1):44–48. doi: 10.3928/23258160-20150101-07.
    1. Mate A, de Smet Air as tamponade for retinal detachments. Eur J Ophthalmol. 2014;24(2):242–246. doi: 10.5301/ejo.5000373.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir