Vitreous Hyper Reflective Dots in Association With Pseudo... | NCT05811182

Studies
Vitreous Hyper Reflective Dots in Association With Pseudophakic Cystoid Macular Edema

NCT05811182

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Apr 13, 2023Actual

Enrollment

97Actual

Phase

Not provided

Conditions

Cystoid Macular Edema Following Cataract Surgery
Vitreous Hyperreflective Dots

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Mar 1, 2023

First Submission Date that Met QC Criteria

Apr 12, 2023

First Posted Date

Apr 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2023

Last Update Posted Date

Apr 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz	Styria	8036	Austria