Vitreous Hyper Reflective Dots in Association With Pseudophakic Cystoid Macular Edema

April 12, 2023 updated by: Medical University of Graz

Prospective Analysis of the Correlation Between Hyperreflective Dots in the Vitreous Body and the Appearance of a Pseudophakic Cystoid Macular Edema

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cataract surgery using the manual anterior continuous curvilinear capsulorhexis phacoemulsification technique for the removal of the crystalline lens and subsequent implantation of a monofocal hydrophobic acrylic intraocular lens in the capsular bag

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vitreous hyperreflective dots
Time Frame: preoperatively until 3 months postoperatively
Change of correlation between occurrence of vitreous hyperreflective dots and the macular thickness
preoperatively until 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Estimate)

April 13, 2023

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30-273 ex 17/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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