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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Macular Holes, Retinal Detachment, High Myopia

Intervention / Treatment
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* Procedure: Group 1
* Procedure: Group 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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; Drop out; The patients voluntarily withdraw the informed consent; Serious violation of the study protocol due to the subjects or investigators' reasons; Other reasons that the researchers believe for quitting the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Operation mode, Air tamponade, High myopia, Macular hole retinal detachment