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

A Single Center, Randomized and Controlled Clinical Study of Inverted Internal Limiting Membrane Insertion Combined With Air Tamponade in the Treatment of Macular Hole Retinal Detachment in High Myopia

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

Study Overview

• Status: Unknown
• Conditions: Retinal Detachment; High Myopia; Macular Holes
• Intervention / Treatment: Procedure: Group 1; Procedure: Group 2

Detailed Description

This study uses a new surgical method (vitrectomy combined with inverted internal limiting membrane insertion and intraocular sterilized air tamponade) to assess its effectiveness and safety on the prognosis of macular hole retinal detachment secondary to high myopia, and also compares this new type of surgery with the current commonly used surgery (vitrectomy combined with internal limiting membrane peeling + silicone oil infusion).

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fenghua Wang; Phone Number: +8618917504061; Email: shretina@sjtu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Recruiting
      • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Fenghua Wang; Phone Number: +8618917504061; Email: shretina@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Failure to comply with research or follow-up procedures;
2. 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;
3. Poor control of blood pressure in hypertensive patients (defined as blood pressure >150/95mmHg, including antihypertensive medication);
4. With surgical contraindication due to other local or systemic conditions at screening or baseline;
5. With any active ocular or periocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at screening or baseline;
6. With uncontrolled glaucoma at screening or baseline (IOP ≥ 30mmHg when receiving medical treatment or as judged by the researchers);
7. With the presence of iris neovascularization or neovascular glaucoma at screening or baseline;
8. 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;
9. With other causes which may result in macular hole associated-retinal detachment at screening or baseline,except high myopia;
10. Previously underwent scleral buckling surgery;
11. 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;
12. 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;
13. 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:

1. Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;
2. Drop out;
3. The patients voluntarily withdraw the informed consent;
4. Serious violation of the study protocol due to the subjects or investigators' reasons;
5. Other reasons that the researchers believe for quitting the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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; the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion
Experimental: Group 2; 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; the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular hole closure rate	Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery.	3 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Best corrected visual acuity are performed 6 months after the surgery.	6 months after the operation
Best corrected visual acuity	Best corrected visual acuity are performed 12 months after the surgery.	12 months after the operation
Reattachment rate of retinal detachment	Use fundus examination combined with B-scan ultrasound, optical coherence tomography (OCT) to observe the reattachment rate of retinal detachment within 12 months after the surgery.(The reattachment rate assessment is performed 12 months after the first surgery among the patients with air tamponade. The reattachment rate assessment is performed 12 months after the first surgery among the patients with silicone oil tamponade, and the silicone oil removal is performed 6 months after the previous surgery.)	6 months after the operation
Reattachment rate of retinal detachment	Use fundus examination combined with B-scan ultrasound, optical coherence tomography (OCT) to observe the reattachment rate of retinal detachment within 12 months after the surgery.(The reattachment rate assessment is performed 12 months after the first surgery among the patients with air tamponade. The reattachment rate assessment is performed 12 months after the first surgery among the patients with silicone oil tamponade, and the silicone oil removal is performed 6 months after the previous surgery.)	12 months after the operation
Postoperative complication rate of ocular adverse events	Evaluate the ocular adverse events within 12 months after operation.	Within 12 months after operation
Postoperative complication rate of the non ocular adverse events	Evaluate the non ocular adverse events within 12 months after operation.	Within 12 months after operation
Postoperative complication rate of severe adverse events	Evaluate the severe adverse events within 12 months after operation.	Within 12 months after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of people whose best corrected visual acuity (BCVA) result improves	The number of people whose BCVA result improves by more than 1 row, 2 rows and 3 rows comparing to the baseline at a time	12 months after the operation
The number of people whose BCVA result decreases	The number of people whose BCVA result decreases by 3 rows comparing to the baseline at a time	12 months after the operation
The difference of multifocal electroretinogram (ERG) results	The difference of multifocal ERG results between each group from 1 week to the 6th month after surgery	6 months after the operation
The difference of multifocal ERG results	The difference of multifocal ERG results between each group from 1 week to the 12th month after surgery	12 months after the operation
The change of microperimetry analysis results	The change of microperimetry analysis results from 1 week to the 6th month after surgery relative to baseline, and the difference between each group	6 months after the operation
The change of microperimetry analysis results	The change of microperimetry analysis results from 1 week to the 12th month after surgery relative to baseline, and the difference between each group	12 months after the operation
The change of the extent of foveal ellipsoid zone damage	The change of the extent of foveal ellipsoid zone damage from baseline to the 6th month after the surgery relative to baseline, and the difference between each group	6 months after the operation
The change of the external limiting membrane integrity of fovea	The change of the external limiting membrane integrity of fovea from baseline to the 6th month after the surgery relative to baseline, and the difference between each group	6 months after the operation
The change of the extent of foveal ellipsoid zone damage	The change of the extent of foveal ellipsoid zone damage from baseline to the 12th month after the surgery relative to baseline, and the difference between each group	12 months after the operation
The change of the external limiting membrane integrity of fovea	The change of the external limiting membrane integrity of fovea from baseline to the 12th month after the surgery relative to baseline, and the difference between each group	12 months after the operation
The number of retreatment and retreatment modalities	λ Describe the number of retreatment and retreatment modalities for patients with different surgical procedures over a period of 12 months	within 12 months after the operation

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Fenghua Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2017
• Primary Completion (Anticipated): April 6, 2020
• Study Completion (Anticipated): April 6, 2020

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: High myopia; Air tamponade; Operation mode; Macular hole retinal detachment
• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Refractive Errors; Myopia; Retinal Perforations; Retinal Detachment; Dissociative Disorders
• Other Study ID Numbers: Shanghai1stWFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Statistical Analysis Plan that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: Dr Fenghua Wang and Dr Ying Zheng will review requests and criteria.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No