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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT03383731

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Macular Holes Retinal Detachment High Myopia	Procedure: Group 1 Procedure: Group 2	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 exchangeThis 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 (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..

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 7, 2017

Anticipated Primary Completion Date :

Apr 6, 2020

Anticipated Study Completion Date :

Apr 6, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Macular hole closure rate [3 months after operation]
Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery.

Secondary Outcome Measures

Best corrected visual acuity [6 months after the operation]
Best corrected visual acuity are performed 6 months after the surgery.
Best corrected visual acuity [12 months after the operation]
Best corrected visual acuity are performed 12 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.)
Reattachment rate of retinal detachment [12 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 Outcome Measures

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 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 microperimetry analysis results [12 months after the operation]
The change of microperimetry analysis results from 1 week to the 12th 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
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 change of the extent of foveal ellipsoid zone damage [12 months after the operation]
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
The change of the external limiting membrane integrity of fovea [12 months after the operation]
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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