Macular HolesNCT03383731
A Study of a New Surgical Treatment of Macular Hole Retinal Detachment in High Myopia
A study testing Group 1 and Group 2 in people with Macular Holes and Retinal Detachment, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Macular Holes, Retinal Detachment, High Myopia
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2017to 6 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200080
Fenghua Wang, +8618917504061, shretina@sjtu.edu.cn
About this study
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
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
Read the 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).
- Conditions
- Macular Holes, Retinal Detachment, High Myopia
- Being tested
- Group 1, Group 2
- Keywords
- Operation mode, Air tamponade, High myopia, Macular hole retinal detachment
- Medical subject headings
- Retinal Perforations, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Procedure or surgery
the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion
Group 2Procedure or surgery
the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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 Receives: Procedure: Group 1 |
| Group 2 | Experimental | 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 Receives: Procedure: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure rate
Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery.
Measured: 3 months after operation
Secondary outcomes (7)
Best corrected visual acuity
Best corrected visual acuity are performed 6 months after the surgery.
Measured: 6 months after the operation
Best corrected visual acuity
Best corrected visual acuity are performed 12 months after the surgery.
Measured: 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.)
Measured: 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.)
Measured: 12 months after the operation
Postoperative complication rate of ocular adverse events
Evaluate the ocular adverse events within 12 months after operation.
Measured: 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.
Measured: Within 12 months after operation
Postoperative complication rate of severe adverse events
Evaluate the severe adverse events within 12 months after operation.
Measured: Within 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start7 Apr 2017
- Primary completion6 Apr 2020 (estimated)
- Study completion6 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fenghua Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Fenghua Wang, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383731
- Sponsor's protocol ID
- Shanghai1stWFH
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical Analysis Plan that underlie results in a publication
Publications
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.
PubMed 4595402Hong 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.
PubMed 21421206Miyake 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.
PubMed 3741257Mete 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.
PubMed 21080197Soheilian 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.
PubMed 17278531Li 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.
PubMed 19375168Uemoto 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.
PubMed 15300077Lim 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.
PubMed 24139155Shin 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.
PubMed 25154029Michalewska 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.
PubMed 25946691Kuriyama 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.
PubMed 23622567Hasegawa 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.
PubMed 19544065He 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.
PubMed 25559508Mateo-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.
PubMed 24170524Zheng 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.
PubMed 30165894
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03383731
- Acronym / sponsor ID
- Shanghai1stWFH
- Conditions
- Macular Holes, Retinal Detachment, High Myopia
- Keywords
- Operation mode, Air tamponade, High myopia, Macular hole retinal detachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 6 Apr 2020 (estimated)
- Study completion
- 6 Apr 2020 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Group 1Group 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 |
| Group 2 | Experimental | Procedure: Group 2Group 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion | Procedure or surgery | Group 1 |
| Group 2the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange | Procedure or surgery | Group 2 |
Primary outcome
Macular hole closure rate
Time frame: 3 months after operation
Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery.
7 secondary outcomes
Best corrected visual acuity
Time frame: 6 months after the operation
Best corrected visual acuity
Time frame: 12 months after the operation
Reattachment rate of retinal detachment
Time frame: 6 months after the operation
Reattachment rate of retinal detachment
Time frame: 12 months after the operation
Postoperative complication rate of ocular adverse events
Time frame: Within 12 months after operation
Postoperative complication rate of the non ocular adverse events
Time frame: Within 12 months after operation
Postoperative complication rate of severe adverse events
Time frame: Within 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Background: PubMed 4595402Feman 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.
- Background: PubMed 21421206Hong 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.
- Background: PubMed 3741257Miyake 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.
- Background: PubMed 21080197Mete 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.
- Background: PubMed 17278531Soheilian 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.
- Background: PubMed 19375168Li 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.
- Background: PubMed 15300077Uemoto 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.
- Background: PubMed 24139155Lim 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.
- Background: PubMed 25154029Shin 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.
- Background: PubMed 25946691Michalewska 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.
- Background: PubMed 23622567Kuriyama 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.
- Background: PubMed 19544065Hasegawa 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.
- Individual participant dataSharing planned: Yes. Statistical Analysis Plan that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fenghua Wang principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 and Group 2 in people with Macular Holes and Retinal Detachment, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fenghua Wang (+8618917504061, shretina@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular hole closure rate (time frame: 3 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383731, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.