NCT05811182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

March 1, 2023

Last Update Submit

April 12, 2023

Conditions

Cystoid Macular Edema Following Cataract SurgeryVitreous Hyperreflective Dots

Keywords

VHDphacoemulsificationCME

Outcome Measures

Primary Outcomes (1)

  • vitreous hyperreflective dots

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

    preoperatively until 3 months postoperatively

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • patients undergoing cataract surgery
  • minimum age 18 years
  • phacoemulsification technique
  • subsequent implantation of a monofocal hydrophobic acrylic intraocular lens

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

April 13, 2023

Study Start

July 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

AU(1)