An interventional study of Group 1 and Group 2 in Macular Holes, Retinal Detachment and High Myopia, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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
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).
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 38 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exit criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 + air-fluid exchange + silicone oil infusion
the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange
Macular hole closure rate
Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery.
Time frame: 3 months after operation
Best corrected visual acuity
Best corrected visual acuity are performed 6 months after the surgery.
Time frame: 6 months after the operation
Best corrected visual acuity
Best corrected visual acuity are performed 12 months after the surgery.
Time frame: 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.)
Time frame: 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.)
Time frame: 12 months after the operation
Postoperative complication rate of ocular adverse events
Evaluate the ocular adverse events within 12 months after operation.
Time frame: 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.
Time frame: Within 12 months after operation
Postoperative complication rate of severe adverse events
Evaluate the severe adverse events within 12 months after operation.
Time frame: Within 12 months after operation
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 12 months after the operation
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Statistical Analysis Plan that underlie results in a publication
Supporting information: Statistical analysis plan
Time frame: starting 6 months after publication
Access criteria: Dr Fenghua Wang and Dr Ying Zheng will review requests and criteria.
Started Apr 2017 (actual). Primary completion is estimated for Apr 2020, 35 months after the start.
Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 35 months is above that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine →