Optic Disc Pit MaculopathyNCT01340703
Vitrectomy for Optic Disc Pit Maculopathy
A study testing vitrectomy without laser or gas tamponade in people with Optic Disc Pit Maculopathy, run by Kyorin University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or laser photocoagulation to the margin of the optic nerve, for the treatment of macular detachment associated with optic disc pits and to characterize retinal manifestations during treatment of optic pit maculopathy using… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Optic Disc Pit Maculopathy
- What is being tested?
- vitrectomy without laser or gas tamponade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2005to Jan 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- eyes with optic disc pit maculopathy
Who cannot join
- eyes without macular elevation associated with optic disc pit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitrectomy Without Laser or Gas Tamponade for Optic Disc Pit Maculopathy
The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or laser photocoagulation to the margin of the optic nerve, for the treatment of macular detachment associated with optic disc pits and to characterize retinal manifestations during treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears to be an effective method of managing macular detachment due to optic disc pits. OCT scanning pre- and postoperatively suggests that peripapillary vitreous traction with the passage of fluid into the retina through the pit is the cause of the schisis-like separation seen in optic disc pit maculopathy.
- Conditions
- Optic Disc Pit Maculopathy
- Being tested
- vitrectomy without laser or gas tamponade
- Keywords
- optic disc pit, retinal detachment, retinoschisis, vitrectomy, posterior vitreous detachment
- Medical subject headings
- Retinal Detachment, Retinoschisis, Vitreous Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy without laser or gas tamponadeProcedure or surgery
vitrectomy without laser or gas tamponade
| Study group | Role | What they receive |
|---|---|---|
| optic disc pit maculopathy | Other | Not described Receives: Procedure: vitrectomy without laser or gas tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical result
resolution of retinal detachment or retinoschisis
Measured: one year
Secondary outcomes (1)
visual acuity
preoperative and postoperative visual acuity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startJan 2005
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Disc Pit MaculopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Investigators
- Akito Hirakata, MD, Principal investigator, Kyroin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340703
- Sponsor's protocol ID
- KyorinEye005
- Status last verified
- Jan 2011
- First submitted
- 21 Apr 2011
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitrectomy Without Laser or Gas Tamponade for Optic Disc Pit Maculopathy
- ClinicalTrials.gov ID
- NCT01340703
- Acronym / sponsor ID
- KyorinEye005
- Conditions
- Optic Disc Pit Maculopathy
- Keywords
- optic disc pit, retinal detachment, retinoschisis, vitrectomy, posterior vitreous detachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Apr 2011 (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.
The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or laser photocoagulation to the margin of the optic nerve, for the treatment of macular detachment associated with optic disc pits and to characterize retinal manifestations during treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears to be an effective method of managing macular detachment due to optic disc pits. OCT scanning pre- and postoperatively suggests that peripapillary vitreous traction with the passage of fluid into the retina through the pit is the cause of the schisis-like separation seen in optic disc pit maculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| optic disc pit maculopathy | Other | Procedure: vitrectomy without laser or gas tamponade |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- eyes with optic disc pit maculopathy
Key exclusion criteria (1 listed)
- eyes without macular elevation associated with optic disc pit
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 |
|---|---|---|
| vitrectomy without laser or gas tamponadevitrectomy without laser or gas tamponade | Procedure or surgery | optic disc pit maculopathy |
Primary outcome
anatomical result
Time frame: one year
resolution of retinal detachment or retinoschisis
1 secondary outcome
visual acuity
Time frame: one year
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 22 Apr 2011.
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.
Akito Hirakata, MD principal investigator
Kyroin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitrectomy without laser or gas tamponade in people with Optic Disc Pit Maculopathy, run by Kyorin University at 1 site in Japan.
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 1 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 22 Apr 2011. 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 Japan. 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?
anatomical result (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2011.