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Changes InMPOD After Full-thickness Macular Hole Closure

Changes in Macular Pigment Optical Density After Full-thickness Macular Hole Closure Using Inverted Flap Technique

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06664515
Enrollment
15
Registered
2024-10-29
Start date
2023-06-01
Completion date
2024-10-01
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full Macular Hole

Brief 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.

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.

Interventions

PROCEDURECiro Costagliola

invert flap tecnique

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

age older than 60 years * diagnosis of FTHM * absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
MPOD After Full-thickness Macular Hole Closure (FTMH)6 monthsThe parameters analyzed by OCT and MPOD six months after surgery are: OCT MPOD visual acuity
MPOD and Macula hole: before and after surgerysix monthsThe parameters analyzed six months after surgery are: MPOD Visual acuity OCT

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026