Changes InMPOD After Full-thickness Macular Hole Closure

Completed

• Conditions: Full Macular Hole

• Registration Number: NCT06664515
• Lead Sponsor: Federico II University

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 Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-07-01
• Status Verified: 2024-10
• Study Completion: 2024-10-01
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Study First Posted: 2024-10-29
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MPOD After Full-thickness Macular Hole Closure (FTMH)	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	six months	The parameters analyzed six months after surgery are: MPOD Visual acuity OCT

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy