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OpenTrials
Completed

NCT Number: NCT06664515

Changes InMPOD After Full-thickness Macular Hole Closure

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, Italy, 80100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ciro Costagliola

Procedure

invert flap tecnique

Primary outcomes

  1. 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

  2. MPOD and Macula hole: before and after surgery

    Time frame: six months

    The parameters analyzed six months after surgery are:

    MPOD Visual acuity OCT

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 29, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.