Clinical trial NCT03383731: A Study of a New Surgical Treatment of Macular Hole Retinal Detachment in High Myopia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Holes
Retinal Detachment
High Myopia
Keywords: Operation mode
Air tamponade
High myopia
Macular hole retinal detachment
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Macular hole closure rate
timeFrame: 3 months after operation
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 6 months after the operation
measure: Best corrected visual acuity
timeFrame: 12 months after the operation
measure: Reattachment rate of retinal detachment
timeFrame: 6 months after the operation
measure: Reattachment rate of retinal detachment
timeFrame: 12 months after the operation
measure: Postoperative complication rate of ocular adverse events
timeFrame: Within 12 months after operation
measure: Postoperative complication rate of the non ocular adverse events
timeFrame: Within 12 months after operation
measure: Postoperative complication rate of severe adverse events
timeFrame: Within 12 months after operation
Other outcomes:
measure: The number of people whose best corrected visual acuity (BCVA) result improves
timeFrame: 12 months after the operation
measure: The number of people whose BCVA result decreases
timeFrame: 12 months after the operation
measure: The difference of multifocal electroretinogram (ERG) results
timeFrame: 6 months after the operation
measure: The difference of multifocal ERG results
timeFrame: 12 months after the operation
measure: The change of microperimetry analysis results
timeFrame: 6 months after the operation
measure: The change of microperimetry analysis results
timeFrame: 12 months after the operation
measure: The change of the extent of foveal ellipsoid zone damage
timeFrame: 6 months after the operation
measure: The change of the external limiting membrane integrity of fovea
timeFrame: 6 months after the operation
measure: The change of the extent of foveal ellipsoid zone damage
timeFrame: 12 months after the operation
measure: The change of the external limiting membrane integrity of fovea
timeFrame: 12 months after the operation
measure: The number of retreatment and retreatment modalities
timeFrame: within 12 months after the operation
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Fenghua Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.