Retinal DetachmentNCT03707015
Internal Limiting Membrane Flap in the Management of Retinal Detachment Due to Paracentral Retinal Breaks
An observational study of Retinal Detachment and Surgery, run by San Ni Chen.
Trial summary
To describe the technique and outcomes of using either inverted or free internal limiting membrane flap in the management of retinal detachment due to paracentral retinal breaks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment, Surgery
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We included patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018. Eyes with macular hole were excluded. All of the cases underwent standard pars plana vitrectomy using the ILM flap technique, accompanied by extended gas tamponade without laser retinopexy
Who may be able to join
- Patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018
Who cannot join
- Patient with macular hole
- Patient with other ocular diseases including ocular hypertension, optic nerve atrophy, glaucoma or chronic uveitis
About this study
To describe the technique and outcomes of using either inverted or free internal limiting membrane flap in the management of retinal detachment due to paracentral retinal breaks.
Read the detailed description
This retrospective observational case series includes nine patients received surgery for retinal detachment due to paracentral retinal breaks developed either from primary rhegmatogenous orgin, or secondary iatrogenic retinal breaks after prior membrane peeling or during surgery for tractional retinal detachment. Either inverted or free internal limiting membrane flaps were inserted in the identified breaks, followed by air fluid exchange and gas tamponade. Visual acuity and structural changes were evaluated.
- Conditions
- Retinal Detachment, Surgery
- Keywords
- Retinal Detachment; internal limiting membrane flap; retinal paracentral breaks
- Medical subject headings
- Retinal Detachment
What is being measured
The primary outcome is the main question the study is designed to answer.
re-attachment rate of retinal detachment
re-attachment of retina through examination including fundoscopic exam and optical coherent tomography exam
Measured: within 3 months postoperatively
Secondary outcomes (1)
visual acuity
visual acuity in logMAR
Measured: within 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study startJan 2017
- Primary completionJun 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Ni Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, San Ni Chen, Changhua Christian Hospital
- Investigators
- San-Ni Chen, M.D, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707015
- Sponsor's protocol ID
- 180315
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen SN, Yang CM. Inverted Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment in High Myopia. Am J Ophthalmol. 2016 Feb;162:99-106.e1. doi: 10.1016/j.ajo.2015.11.013. Epub 2015 Nov 12.
PubMed 26582311Chen SN, Hsieh YT, Yang CM. Multiple Free Internal Limiting Membrane Flap Insertion in the Treatment of Macular Hole-Associated Retinal Detachment in High Myopia. Ophthalmologica. 2018;240(3):143-149. doi: 10.1159/000487337. Epub 2018 Jun 6.
PubMed 29874671Chen YC, Yang CM, Chen SN. Internal Limiting Membrane Flap in the Management of Retinal Detachment due to Paracentral Retinal Breaks. J Ophthalmol. 2019 Jan 21;2019:4303056. doi: 10.1155/2019/4303056. eCollection 2019.
PubMed 30805208
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Limiting Membrane Flap in the Management of Retinal Detachment Due to Paracentral Retinal Breaks
- ClinicalTrials.gov ID
- NCT03707015
- Acronym / sponsor ID
- 180315
- Conditions
- Retinal Detachment, Surgery
- Keywords
- Retinal Detachment; internal limiting membrane flap; retinal paracentral breaks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- San Ni ChenUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Oct 2018 (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.
To describe the technique and outcomes of using either inverted or free internal limiting membrane flap in the management of retinal detachment due to paracentral retinal breaks.
Detailed description
This retrospective observational case series includes nine patients received surgery for retinal detachment due to paracentral retinal breaks developed either from primary rhegmatogenous orgin, or secondary iatrogenic retinal breaks after prior membrane peeling or during surgery for tractional retinal detachment. Either inverted or free internal limiting membrane flaps were inserted in the identified breaks, followed by air fluid exchange and gas tamponade. Visual acuity and structural changes were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We included patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018. Eyes with macular hole were excluded. All of the cases underwent standard pars plana vitrectomy using the ILM flap technique, accompanied by extended gas tamponade without laser retinopexy
Key inclusion criteria (1 listed)
- Patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018
Key exclusion criteria (2 listed)
- Patient with macular hole
- Patient with other ocular diseases including ocular hypertension, optic nerve atrophy, glaucoma or chronic uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
re-attachment rate of retinal detachment
Time frame: within 3 months postoperatively
re-attachment of retina through examination including fundoscopic exam and optical coherent tomography exam
1 secondary outcome
visual acuity
Time frame: within 3 months postoperatively
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 16 Oct 2018.
- Results publication: PubMed 26582311Chen SN, Yang CM. Inverted Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment in High Myopia. Am J Ophthalmol. 2016 Feb;162:99-106.e1. doi: 10.1016/j.ajo.2015.11.013. Epub 2015 Nov 12.
- Results publication: PubMed 29874671Chen SN, Hsieh YT, Yang CM. Multiple Free Internal Limiting Membrane Flap Insertion in the Treatment of Macular Hole-Associated Retinal Detachment in High Myopia. Ophthalmologica. 2018;240(3):143-149. doi: 10.1159/000487337. Epub 2018 Jun 6.
- Derived from this study: PubMed 30805208Chen YC, Yang CM, Chen SN. Internal Limiting Membrane Flap in the Management of Retinal Detachment due to Paracentral Retinal Breaks. J Ophthalmol. 2019 Jan 21;2019:4303056. doi: 10.1155/2019/4303056. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
San-Ni Chen, M.D principal investigator
Changhua Christian Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment and Surgery, run by San Ni Chen.
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 1 inclusion and 2 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
re-attachment rate of retinal detachment (time frame: within 3 months postoperatively). 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 NCT03707015, which also lists 3 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 16 Oct 2018.