Changes InMPOD After Full-thickness Macular Hole Closure

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.

Study Overview

• Status: Completed
• Conditions: Full Macular Hole
• Intervention / Treatment: Procedure: Ciro Costagliola

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • University of Naples "Federico II"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients affected by macular hole	Procedure: Ciro Costagliola; invert flap tecnique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPOD After Full-thickness Macular Hole Closure (FTMH)	The parameters analyzed by OCT and MPOD six months after surgery are: OCT MPOD visual acuity	6 months
MPOD and Macula hole: before and after surgery	The parameters analyzed six months after surgery are: MPOD Visual acuity OCT	six months

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Study Chair: Ciro Costagliola, FEDERICOII UNIVERSITY

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: MPOD; OCT; Invert flap
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: 05809853 Federico II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No