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Vitreous Hyper Reflective Dots in Association With Pseudophakic Cystoid Macular Edema

Sponsor
Medical University of Graz (Other)
Overall Status
Completed
CT.gov ID
NCT05811182
Collaborator
(none)
97
Enrollment
1
Location
20
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess the association between vitreous hyper-reflective dots (VHD) and the macular thickness changes following uneventful phacoemulsification. In this prospective study the investigators performed optical coherence tomography (OCT) imaging in patients undergoing cataract surgery preoperatively and postoperatively after 1 week, 1 month and 3 months and analyzed the OCTs for VHDs. The investigators then measured the macular thickness in patients with VHDs and without VHDs and correlated the macular thickness with the number of VHDs.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    97 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Analysis of the Correlation Between Hyperreflective Dots in the Vitreous Body and the Appearance of a Pseudophakic Cystoid Macular Edema
    Actual Study Start Date :
    Jul 1, 2018
    Actual Primary Completion Date :
    Mar 1, 2020
    Actual Study Completion Date :
    Mar 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. vitreous hyperreflective dots [preoperatively until 3 months postoperatively]

      Change of correlation between occurrence of vitreous hyperreflective dots and the macular thickness

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • patients undergoing cataract surgery

    • minimum age 18 years

    • phacoemulsification technique

    • subsequent implantation of a monofocal hydrophobic acrylic intraocular lens

    Exclusion Criteria:

    • intraoperative complications including capsule rupture with or without anterior vitrectomy

    • iris bites

    • previous interventions including vitrectomy

    • glaucoma surgery

    • exudative or dry age-related macular degeneration

    • presence of diabetes

    • history or presence of retinal vein occlusion or uveitis

    • epiretinal glioses

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Graz Graz Styria Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT05811182
    Other Study ID Numbers:
    • 30-273 ex 17/18
    First Posted:
    Apr 13, 2023
    Last Update Posted:
    Apr 13, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Graz
    VHD
    phacoemulsification
    CME
    Additional relevant MeSH terms:
    Cataract
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Apr 13, 2023