A Study of a New Surgical Treatment of Macular Hole Retinal Detachment in High Myopia

NCT03383731 | Unknown

• 1 other identifier: Shanghai1stWFH
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the surgical outcomes of inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment (MHRD) in high myopia, and also to compare the treatment efficacy and safety between different surgical approaches of MHRD

Conditions

Macular Holes; Retinal Detachment; High Myopia

Keywords

Operation mode; Air tamponade; High myopia; Macular hole retinal detachment

Outcome Measures

Primary Outcomes (1)

• Macular hole closure rate

  Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery.

  3 months after operation

Secondary Outcomes (7)

• Best corrected visual acuity

  6 months after the operation

• Best corrected visual acuity

  12 months after the operation

• Reattachment rate of retinal detachment

  6 months after the operation

• Reattachment rate of retinal detachment

  12 months after the operation

• Postoperative complication rate of ocular adverse events

  Within 12 months after operation

Other Outcomes (11)

• The number of people whose best corrected visual acuity (BCVA) result improves

  12 months after the operation

• The number of people whose BCVA result decreases

  12 months after the operation

• The difference of multifocal electroretinogram (ERG) results

  6 months after the operation

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1: The patients in Group 1 are treated by the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion

Procedure: Group 1

Group 2

EXPERIMENTAL

Group 2: The patients in Group 2 are treated by the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange

Procedure: Group 2

Interventions

Group 1 PROCEDURE

the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion

Group 1

Group 2 PROCEDURE

the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange

Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior written informed consent should be obtained before any assessment is carried out;
• Participants are more than 18 years of age, and less than 75 years of age, male or female Chinese patients;
• Visual impairment is caused by macular hole associated with retinal detachment secondary to high myopia;
• Axial length ≥ 26mm, or the refractive error ≥ -6.0D

You may not qualify if:

• Failure to comply with research or follow-up procedures;
• Diabetes with uncontrolled blood glucose (defined as fasting plasma glucose more than 7.0mmol/L or blood glucose more than 11.1mmol/ L 2 hours postprandial), and / or with diabetic retinopathy;
• Poor control of blood pressure in hypertensive patients (defined as blood pressure \>150/95mmHg, including antihypertensive medication);
• With surgical contraindication due to other local or systemic conditions at screening or baseline;
• With any active ocular or periocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at screening or baseline;
• With uncontrolled glaucoma at screening or baseline (IOP ≥ 30mmHg when receiving medical treatment or as judged by the researchers);
• With the presence of iris neovascularization or neovascular glaucoma at screening or baseline;
• With ocular diseases which may interfere the study results at screening or baseline , including severe vitreous hemorrhage, peripheral retinal hole, proliferative diabetic retinopathy, proliferative vitreoretinopathy ( ≥ Level C ), choroidal detachment;
• With other causes which may result in macular hole associated-retinal detachment at screening or baseline,except high myopia;
• Previously underwent scleral buckling surgery;
• With current or planned medication known to have toxic effects on the lens, retina or optic nerve, including hydroxychloroquine, chloroquine, hydroxychloroquine, tamoxifen, phenothiazine and ethambutol;
• With laboratory abnormalities, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), exceeded the normal limit by more than 2 times, and serum creatinine or blood urea nitrogen exceeded 1.2 times the normal limit;
• With abnormal coagulation function (defined as more than normal prothrombin time for 3 seconds or more, more than 1.5 of the international standard ratio (INR), activated partial thromboplastin time of 10 seconds or longer than the upper limit of normal time); 14) Patients who participated in any clinical study of medication within 3 months prior to screening (excluding vitamins and minerals)
• Exit criteria:
• Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (15)

• Feman SS, Hepler RS, Straatsma BR. Rhegmatogenous retinal detachment due to macular hole. Management with cryotherapy and a Y-shaped sling. Arch Ophthalmol. 1974 May;91(5):371-2. doi: 10.1001/archopht.1974.03900060383007. No abstract available.

  PMID: 4595402 BACKGROUND

• Hong MC, Wu TT, Sheu SJ. Primary gas tamponade in the management of macular hole with retinal detachment in highly myopic eyes. J Chin Med Assoc. 2011 Mar;74(3):121-4. doi: 10.1016/j.jcma.2011.01.026. Epub 2011 Feb 25.

  PMID: 21421206 BACKGROUND

• Miyake Y. A simplified method of treating retinal detachment with macular hole. Long-term follow-up. Arch Ophthalmol. 1986 Aug;104(8):1234-6. doi: 10.1001/archopht.1986.01050200140070.

  PMID: 3741257 BACKGROUND

• Mete M, Parolini B, Maggio E, Pertile G. 1000 cSt silicone oil vs heavy silicone oil as intraocular tamponade in retinal detachment associated to myopic macular hole. Graefes Arch Clin Exp Ophthalmol. 2011 Jun;249(6):821-6. doi: 10.1007/s00417-010-1557-9. Epub 2010 Nov 16.

  PMID: 21080197 BACKGROUND

• Soheilian M, Ghaseminejad AK, Yazdani S, Ahmadieh H, Azarmina M, Dehghan MH, Moradian S, Anisian A, Peyman GA. Surgical management of retinal detachment in highly myopic eyes with macular hole. Ophthalmic Surg Lasers Imaging. 2007 Jan-Feb;38(1):15-22. doi: 10.3928/15428877-20070101-02.

  PMID: 17278531 BACKGROUND

• Li X, Wang W, Tang S, Zhao J. Gas injection versus vitrectomy with gas for treating retinal detachment owing to macular hole in high myopes. Ophthalmology. 2009 Jun;116(6):1182-87.e1. doi: 10.1016/j.ophtha.2009.01.003. Epub 2009 Apr 17.

  PMID: 19375168 BACKGROUND

• 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 Aug;24(4):560-6. doi: 10.1097/00006982-200408000-00009.

  PMID: 15300077 BACKGROUND

• Lim LS, Tsai A, Wong D, Wong E, Yeo I, Loh BK, Ang CL, Ong SG, Lee SY. Prognostic factor analysis of vitrectomy for retinal detachment associated with myopic macular holes. Ophthalmology. 2014 Jan;121(1):305-310. doi: 10.1016/j.ophtha.2013.08.033. Epub 2013 Oct 16.

  PMID: 24139155 BACKGROUND

• Shin MK, Park KH, Park SW, Byon IS, Lee JE. Perfluoro-n-octane-assisted single-layered inverted internal limiting membrane flap technique for macular hole surgery. Retina. 2014 Sep;34(9):1905-10. doi: 10.1097/IAE.0000000000000339. No abstract available.

  PMID: 25154029 BACKGROUND

• Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Adelman RA, Nawrocki J. TEMPORAL INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE VERSUS CLASSIC INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE: A Comparative Study. Retina. 2015 Sep;35(9):1844-50. doi: 10.1097/IAE.0000000000000555.

  PMID: 25946691 BACKGROUND

• Kuriyama S, Hayashi H, Jingami Y, Kuramoto N, Akita J, Matsumoto M. Efficacy of inverted internal limiting membrane flap technique for the treatment of macular hole in high myopia. Am J Ophthalmol. 2013 Jul;156(1):125-131.e1. doi: 10.1016/j.ajo.2013.02.014. Epub 2013 Apr 24.

  PMID: 23622567 BACKGROUND

• Hasegawa Y, Hata Y, Mochizuki Y, Arita R, Kawahara S, Kita T, Noda Y, Ishibashi T. Equivalent tamponade by room air as compared with SF(6) after macular hole surgery. Graefes Arch Clin Exp Ophthalmol. 2009 Nov;247(11):1455-9. doi: 10.1007/s00417-009-1120-8. Epub 2009 Jun 21.

  PMID: 19544065 BACKGROUND

• 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 Jan;46(1):44-8. doi: 10.3928/23258160-20150101-07.

  PMID: 25559508 BACKGROUND

• Mateo-Montoya A, de Smet MD. Air as tamponade for retinal detachments. Eur J Ophthalmol. 2014 Mar-Apr;24(2):242-6. doi: 10.5301/ejo.5000373. Epub 2013 Sep 23.

  PMID: 24170524 BACKGROUND

• Zheng Y, Kang M, Wang H, Liu H, Sun T, Sun X, Wang F. 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. Trials. 2018 Aug 30;19(1):469. doi: 10.1186/s13063-018-2833-y.

  PMID: 30165894 DERIVED

MeSH Terms

Conditions

Retinal Perforations; Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Fenghua Wang

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fenghua Wang

CONTACT

+8618917504061; shretina@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, the third party independent evaluation method is used to evaluate the results of the study. The analyzer is in the masking state, and the subjects and the surgeons are in the non-masking state..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral supervisor

Model Details: This is a prospective, randomized, controlled study involving multiple visits within 12 months. The patients with macular hole retinal detachment caused by high myopia are randomly divided into 2 treatment groups. Group 1: standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion Group 2: standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 26, 2017
• Study Start: April 7, 2017
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: starting 6 months after publication
• Access Criteria: Dr Fenghua Wang and Dr Ying Zheng will review requests and criteria.

Locations

CN (1)