High Myopia, Macular Holes, Retinal Detachment
Conditions
Keywords
Operation mode, Air tamponade, High myopia, Macular hole retinal detachment
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).
Interventions
PROCEDUREGroup 1
the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion
PROCEDUREGroup 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
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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..
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular hole closure rate | 3 months after operation | Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | 6 months after the operation | Best corrected visual acuity are performed 6 months after the surgery. |
| Reattachment rate of retinal detachment | 6 months after the operation | 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.) |
| Postoperative complication rate of ocular adverse events | Within 12 months after operation | Evaluate the ocular adverse events within 12 months after operation. |
| Postoperative complication rate of the non ocular adverse events | Within 12 months after operation | Evaluate the non ocular adverse events within 12 months after operation. |
| Postoperative complication rate of severe adverse events | Within 12 months after operation | Evaluate the severe adverse events within 12 months after operation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The change of the external limiting membrane integrity of fovea | 6 months after the operation | 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 |
| The number of people whose best corrected visual acuity (BCVA) result improves | 12 months after the operation | 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 |
| The number of retreatment and retreatment modalities | within 12 months after the operation | λ Describe the number of retreatment and retreatment modalities for patients with different surgical procedures over a period of 12 months |
| The number of people whose BCVA result decreases | 12 months after the operation | The number of people whose BCVA result decreases by 3 rows comparing to the baseline at a time |
| The difference of multifocal electroretinogram (ERG) results | 6 months after the operation | The difference of multifocal ERG results between each group from 1 week to the 6th month after surgery |
| The difference of multifocal ERG results | 12 months after the operation | The difference of multifocal ERG results between each group from 1 week to the 12th month after surgery |
| The change of microperimetry analysis results | 6 months after the operation | The change of microperimetry analysis results from 1 week to the 6th month after surgery relative to baseline, and the difference between each group |
| The change of the extent of foveal ellipsoid zone damage | 6 months after the operation | 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 |
Countries
China
Contacts
Primary ContactFenghua Wang
Outcome results
None listed