Retinal DetachmentRDMHNCT00485199
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
A study testing Pneumatic Retinopexy and Vitrectomy with Gas in people with Retinal Detachment, run by Peking University at 14 sites in China.
Trial summary
To undertake a prospective randomized clinical study for treating retinal detachment due to myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Pneumatic Retinopexy and Vitrectomy with Gas
- Type of treatment
- Surgery or procedure
- How many people
- 231 participants
- Where
- 14 sitesChina
- Study dates
- Jan 2005to Dec 2006
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- retinal detachment due to myopic macular hole.
- The ability to give informed consent and to return for follow-up visit for 12 months
Who cannot join
- retinal detachment with macular hole and peripheral hole/tear
- retinal detachment with severe proliferative vitreoretinopathy
- retinal detachment with choroidal detachment or rupture
- traction retinal detachment due to retinal vascular disease
- had vitrectomy in the past
- macular hole without retinal detachment
- foveal schiesis without retinal detachment
- secondary macular hole with retinal detachment
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Department of ophthalmology of People Hospital, Peking University
Beijing, Beijing Municipality, 100044
Department of ophthalmology of Beijing Hospital
Beijing, Beijing Municipality
Department of ophthalmology of Beijing Tong Ren Hospital
Beijing, Beijing Municipality
Department of ophthalmology of China PLA General Hospital
Beijing, Beijing Municipality
Peking Eye Center of the third affiliated Hospital of Peking University
Beijing, Beijing Municipality
Department of ophthalmology of The Second affiliated Xiang Ya Hospital, Central South University
Changsha, Hunan
Department of ophthalmology of West China Hospital, Sichuan University
Chengdu, Sichuan
Zhong Shan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong
Department of ophthalmology of The First affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Shandong Eye Institute
Qingdao, Shandong
Department of ophthalmology of EENT Hospital, Fudan University
Shanghai, Shanghai Municipality
Department of ophthalmology of The First affiliated People Hospital of Shang Hai Jiao Tong University
Shanghai, Shanghai Municipality
Department of ophthalmology of The First affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
About this study
To undertake a prospective randomized clinical study for treating retinal detachment due to myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole.
Read the detailed description
Retinal detachment caused by macular hole predominantly happened in high myopic eyes. This is a common type of retinal detachment in Asia and often seen in the old people aged around 50 ~ 60, mainly in female. Treatment of retinal detachment due to macular holes has changed over the years, and several methods have been described. Some surgeons have used transscleral diathermy or cryotherapy or laser photocoagulation and drainage subretinal fluid without sclera buckling, other surgeons have used radial silicone explants beneath the macular combined with cryo, diathermy or laser. This method entails the difficulty of placing sclera sutures far posterior, especially hazardous if there is a posterior staphyloma with very thin sclera. Besides the technically difficult, the extensive macular scarring caused by different coagulations limited the functional result to peripheral vision only. Because of this, it is not generally used in the initial treatment.
In 1982, Gonvers and Machemer4 proposed a new treatment technique that combined pars plana vitrectomy (PPV), partial air-fluid exchange, and face down positioning for 24 hours. Since then vitrectomy with gas tamponade become the most common procedure for retinal detachment with macular hole.
In 1984, Miyake performed a simple gas injection into the vitreous followed by a face-down position. The effective of this simplified method was then reported by many observers.But these studies may have insufficiency because of small sample, nonrandomized, no defined eligibility criteria for patients selection.
Intraocular gas tamponade with or without pars plana vitrectomy (PPV) has commonly been performed nowadays. We conducted a multicenter randomized controlled clinical trial to compare their anatomic results and visual outcomes of both surgical techniques, to estimate the efficiency of both surgical methods in the treatment of retinal detachment with myopic macular hole.
- Conditions
- Retinal Detachment
- Being tested
- Pneumatic Retinopexy, Vitrectomy with Gas
- Keywords
- Pneumatic Retinopexy, vitrectomy, retinal detachment, macular hole, treatment, multi-center, Retinal Detachment due to Myopic Macular hole
- Medical subject headings
- Retinal Detachment, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic RetinopexyProcedure or surgery
Vitrectomy with GasProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA improvement,anatomic success
Measured: 1,3,6,9, and 12 months after treatment
Secondary outcomes (2)
costs of treatment
Measured: right after the treatment
complication
Measured: 1,3,6,9, 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJan 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Masking
- Single blind
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Investigators
- Xiaoxin Li, professor, Study chair, Peking UniversityJialiang Zhao, professor, Principal investigator, Eye Institute of Peking Union Hospital, Peking Union Medical CollegeWenji Wang, professor, Principal investigator, Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, ShanghaiShibo Tang, professor, Principal investigator, Zhong Shan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485199
- Sponsor's protocol ID
- RDMH2007-china
- Acronym
- RDMH
- Status last verified
- Jun 2007
- First submitted
- 11 Jun 2007
- Last updated
- 12 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
PubMed 32408387
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
- ClinicalTrials.gov ID
- NCT00485199
- Acronym / sponsor ID
- RDMH / RDMH2007-china
- Conditions
- Retinal Detachment
- Keywords
- Pneumatic Retinopexy, vitrectomy, retinal detachment, macular hole, treatment, multi-center, Retinal Detachment due to Myopic Macular hole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Jun 2007 (estimated)
- 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.
To undertake a prospective randomized clinical study for treating retinal detachment due to myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of retinal detachment due to myopic macular hole.
Detailed description
Retinal detachment caused by macular hole predominantly happened in high myopic eyes. This is a common type of retinal detachment in Asia and often seen in the old people aged around 50 ~ 60, mainly in female. Treatment of retinal detachment due to macular holes has changed over the years, and several methods have been described. Some surgeons have used transscleral diathermy or cryotherapy or laser photocoagulation and drainage subretinal fluid without sclera buckling, other surgeons have used radial silicone explants beneath the macular combined with cryo, diathermy or laser. This method entails the difficulty of placing sclera sutures far posterior, especially hazardous if there is a posterior staphyloma with very thin sclera. Besides the technically difficult, the extensive macular scarring caused by different coagulations limited the functional result to peripheral vision only. Because of this, it is not generally used in the initial treatment.
In 1982, Gonvers and Machemer4 proposed a new treatment technique that combined pars plana vitrectomy (PPV), partial air-fluid exchange, and face down positioning for 24 hours. Since then vitrectomy with gas tamponade become the most common procedure for retinal detachment with macular hole.
In 1984, Miyake performed a simple gas injection into the vitreous followed by a face-down position. The effective of this simplified method was then reported by many observers.But these studies may have insufficiency because of small sample, nonrandomized, no defined eligibility criteria for patients selection.
Intraocular gas tamponade with or without pars plana vitrectomy (PPV) has commonly been performed nowadays. We conducted a multicenter randomized controlled clinical trial to compare their anatomic results and visual outcomes of both surgical techniques, to estimate the efficiency of both surgical methods in the treatment of retinal detachment with myopic macular hole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- retinal detachment due to myopic macular hole.
- The ability to give informed consent and to return for follow-up visit for 12 months
Key exclusion criteria (8 listed)
- retinal detachment with macular hole and peripheral hole/tear
- retinal detachment with severe proliferative vitreoretinopathy
- retinal detachment with choroidal detachment or rupture
- traction retinal detachment due to retinal vascular disease
- had vitrectomy in the past
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 |
|---|---|---|
| Pneumatic Retinopexy | Procedure or surgery | – |
| Vitrectomy with Gas | Procedure or surgery | – |
Primary outcome
BCVA improvement,anatomic success
Time frame: 1,3,6,9, and 12 months after treatment
2 secondary outcomes
costs of treatment
Time frame: right after the treatment
complication
Time frame: 1,3,6,9, 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2007.
- Derived from this study: PubMed 32408387Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
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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.
Xiaoxin Li, professor study chair
Peking University
Jialiang Zhao, professor principal investigator
Eye Institute of Peking Union Hospital, Peking Union Medical College
Wenji Wang, professor principal investigator
Department of ophthalmology of Eye Ear Nose Throat Hospital, Fudan University, Shanghai
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic Retinopexy and Vitrectomy with Gas in people with Retinal Detachment, run by Peking University at 14 sites 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 12 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA improvement,anatomic success (time frame: 1,3,6,9, and 12 months after treatment). 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 NCT00485199, which also lists 1 linked publication.
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 12 Jun 2007.