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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05811182
Other study ID # 30-273 ex 17/18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date March 1, 2020

Study information

Verified date April 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Medical University of Graz Graz Styria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary vitreous hyperreflective dots Change of correlation between occurrence of vitreous hyperreflective dots and the macular thickness preoperatively until 3 months postoperatively
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