Optic Disc Structural AnomalyNCT03185936
Surgical Management of Optic Disc Pit Maculaopathy
A study testing pars plana vitrectomy with internal limiting membrane (ILM) peeling in people with Optic Disc Structural Anomaly and Maculopathy, run by Minia University.
Trial summary
To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Optic Disc Structural Anomaly, Maculopathy
- What is being tested?
- pars plana vitrectomy with internal limiting membrane (ILM) peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 1 Apr 2017
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients included in this study are those with ODP associated with macular detachment
Who cannot join
- Exclusion criteria included patients unfit for general anesthesia, those with insufficient clear media to perform the surgery with ILM peeling and those with other ocular diseases that can affect central macular thickness (CMT) and the best corrected visual acuity (BCVA).
About this study
Official title: Pars Plana Vitrectomy With Internal Limiting Membrane Peeling in Optic Disc Pit Maculopathy
To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
Read the detailed description
As it is well known, optic disc pit (ODP) is a rare congenital disease which is usually associated with maculopathy (ODP-M) in the form of intraretinal and subretinal fluid accumulation at the macular area leading to visual impairment.
With no definite treatment and absence of guidelines for its management, the invistigators considered their prospective, interventional case series to evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
- Conditions
- Optic Disc Structural Anomaly, Maculopathy
- Being tested
- pars plana vitrectomy with internal limiting membrane (ILM) peeling
- Keywords
- optic disc pit, retinal detachment, maculopathy
- Medical subject headings
- Macular Degeneration, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomy with internal limiting membrane (ILM) peelingProcedure or surgery
Also called Endolaser photocoagulation
pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
| Study group | Role | What they receive |
|---|---|---|
| Optic disc pit maculopathy | Experimental | pars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser Receives: Procedure: pars plana vitrectomy with internal limiting membrane (ILM) peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical improvement
Retinal reattachment
Measured: 6 months
Secondary outcomes (1)
Functional improvement
Visual acuity letters gain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Mar 2011
- Primary completion1 Apr 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Disc Structural AnomalyStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Genaidy, Minia University
- Investigators
- Mahmud Genaidy, MD, Principal investigator, Assistant professor of ophthalmology, ophthalmology department, Minia university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185936
- Sponsor's protocol ID
- ODP-M
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Can not be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pars Plana Vitrectomy With Internal Limiting Membrane Peeling in Optic Disc Pit Maculopathy
- ClinicalTrials.gov ID
- NCT03185936
- Acronym / sponsor ID
- ODP-M
- Conditions
- Optic Disc Structural Anomaly, Maculopathy
- Keywords
- optic disc pit, retinal detachment, maculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 14 Jun 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.
To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
Detailed description
As it is well known, optic disc pit (ODP) is a rare congenital disease which is usually associated with maculopathy (ODP-M) in the form of intraretinal and subretinal fluid accumulation at the macular area leading to visual impairment.
With no definite treatment and absence of guidelines for its management, the invistigators considered their prospective, interventional case series to evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) 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 | Experimental | Procedure: pars plana vitrectomy with internal limiting membrane (ILM) peelingpars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients included in this study are those with ODP associated with macular detachment
Key exclusion criteria (1 listed)
- Exclusion criteria included patients unfit for general anesthesia, those with insufficient clear media to perform the surgery with ILM peeling and those with other ocular diseases that can affect central macular thickness (CMT) and the best corrected visual acuity (BCVA).
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 |
|---|---|---|
| pars plana vitrectomy with internal limiting membrane (ILM) peelingAlso: Endolaser photocoagulationpars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy. | Procedure or surgery | Optic disc pit maculopathy |
Primary outcome
anatomical improvement
Time frame: 6 months
Retinal reattachment
1 secondary outcome
Functional improvement
Time frame: 6 months
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 14 Jun 2017.
- Individual participant dataSharing planned: No. Can not be shared
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.
Mahmud Genaidy, MD principal investigator
Assistant professor of ophthalmology, ophthalmology department, Minia university, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing pars plana vitrectomy with internal limiting membrane (ILM) peeling in people with Optic Disc Structural Anomaly and Maculopathy, run by Minia University.
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 14 Jun 2017. 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?
anatomical improvement (time frame: 6 months). 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 14 Jun 2017.