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Clinical Trials/NCT06664515
NCT06664515CompletedNot Applicable

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

Federico II University1 site in 1 country15 target enrollmentStarted: June 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
15
Locations
1
Primary Endpoint
MPOD After Full-thickness Macular Hole Closure (FTMH)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts 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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ciro Costagliola

director

Federico II University

Study Sites (1)

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