Full Macular HoleNCT06664515
Changes InMPOD After Full-thickness Macular Hole Closure
An observational study of Full Macular Hole, run by Federico II University at 1 site in Italy.
Trial summary
The notable increase in MPOD following successful surgery suggests its potential role as a valuable adjunctive biomarker associated with a good visual prognosis following this type of macular hole surgical interventions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Full Macular Hole
- What is being tested?
- Ciro Costagliola
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 1 Oct 2024
- How long will I take part?
- 6 Months
- 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: The participans were older than 50 years with diagnosis of FTHM and underwent invert flap surgery.The participans did not present other ophthalmological diseases.
Who may be able to join
- diagnosis of FTHM
- absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration
Who cannot join
- No diagnosis of pseudophakic cystoid macular oedema
- previous treatment for pseudophakic cystoid macular oedema
- presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Macular Pigment Optical Density After Full-thickness Macular Hole Closure Using Inverted Flap Technique
The notable increase in MPOD following successful surgery suggests its potential role as a valuable adjunctive biomarker associated with a good visual prognosis following this type of macular hole surgical interventions.
Read the detailed description
Full-thickness macular hole (FTMH) is a debilitating retinal disorder, particularly in its advanced forms, necessitating surgical intervention for vision restoration. This study showes the successful closure of a large FTMH using the inverted flap technique, highlighting the essential role of multimodal imaging, and particularly of macular pigment optical density (MPOD) assessment, in preoperative and postoperative evaluation.
Surgery was performed by an expert vitreoretinal surgeon, resulting in significant postoperative improvements in visual acuity and retinal architecture. Multimodal imaging, including MPOD assessment, played a pivotal role in preoperative evaluation and postoperative monitoring.
- Conditions
- Full Macular Hole
- Being tested
- Ciro Costagliola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciro CostagliolaProcedure or surgery
invert flap tecnique
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by macular hole | Not described Receives: Procedure: Ciro Costagliola |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPOD After Full-thickness Macular Hole Closure (FTMH)
The parameters analyzed by OCT and MPOD six months after surgery are:
OCT MPOD visual acuity
Measured: 6 months
MPOD and Macula hole: before and after surgery
The parameters analyzed six months after surgery are:
MPOD Visual acuity OCT
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jun 2023
- Primary completion1 Jul 2023
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Macular HoleStudies 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
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Costagliola, Federico II University
- Investigators
- Ciro Costagliola, Study chair, FEDERICOII UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664515
- Sponsor's protocol ID
- 05809853 Federico II
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Macular Pigment Optical Density After Full-thickness Macular Hole Closure Using Inverted Flap Technique
- ClinicalTrials.gov ID
- NCT06664515
- Acronym / sponsor ID
- 05809853 Federico II
- Conditions
- Full Macular Hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 29 Oct 2024 (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.
The notable increase in MPOD following successful surgery suggests its potential role as a valuable adjunctive biomarker associated with a good visual prognosis following this type of macular hole surgical interventions.
Detailed description
Full-thickness macular hole (FTMH) is a debilitating retinal disorder, particularly in its advanced forms, necessitating surgical intervention for vision restoration. This study showes the successful closure of a large FTMH using the inverted flap technique, highlighting the essential role of multimodal imaging, and particularly of macular pigment optical density (MPOD) assessment, in preoperative and postoperative evaluation.
Surgery was performed by an expert vitreoretinal surgeon, resulting in significant postoperative improvements in visual acuity and retinal architecture. Multimodal imaging, including MPOD assessment, played a pivotal role in preoperative evaluation and postoperative monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected by macular hole | – | Procedure: Ciro Costagliola |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participans were older than 50 years with diagnosis of FTHM and underwent invert flap surgery.The participans did not present other ophthalmological diseases.
Key inclusion criteria (2 listed)
- diagnosis of FTHM
- absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration
Key exclusion criteria (3 listed)
- No diagnosis of pseudophakic cystoid macular oedema
- previous treatment for pseudophakic cystoid macular oedema
- presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)
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 |
|---|---|---|
| Ciro Costagliolainvert flap tecnique | Procedure or surgery | Patients affected by macular hole |
Primary outcome
MPOD After Full-thickness Macular Hole Closure (FTMH)
Time frame: 6 months
The parameters analyzed by OCT and MPOD six months after surgery are: OCT MPOD visual acuity
MPOD and Macula hole: before and after surgery
Time frame: six months
The parameters analyzed six months after surgery are: MPOD Visual acuity OCT
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 1 Nov 2024.
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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.
Ciro Costagliola study chair
FEDERICOII UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Full Macular Hole, run by Federico II University at 1 site in Italy.
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 3 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 1 Nov 2024. 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 Italy. 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?
MPOD After Full-thickness Macular Hole Closure (FTMH) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 1 Nov 2024.