Cystoid Macular Edema Following Cataract SurgeryNCT05811182
Vitreous Hyper Reflective Dots in Association With Pseudophakic Cystoid Macular Edema
An observational study of Cystoid Macular Edema Following Cataract Surgery and Vitreous Hyperreflective Dots, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoid Macular Edema Following Cataract Surgery, Vitreous Hyperreflective Dots
- How many people
- 97 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2018to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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
Who may be able to join
- patients undergoing cataract surgery
- minimum age 18 years
- phacoemulsification technique
- subsequent implantation of a monofocal hydrophobic acrylic intraocular lens
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- VHD, phacoemulsification, CME
What is being measured
The primary outcome is the main question the study is designed to answer.
vitreous hyperreflective dots
Change of correlation between occurrence of vitreous hyperreflective dots and the macular thickness
Measured: preoperatively until 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Jul 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystoid Macular Edema Following Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811182
- Sponsor's protocol ID
- 30-273 ex 17/18
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the Correlation Between Hyperreflective Dots in the Vitreous Body and the Appearance of a Pseudophakic Cystoid Macular Edema
- ClinicalTrials.gov ID
- NCT05811182
- Acronym / sponsor ID
- 30-273 ex 17/18
- Keywords
- VHD, phacoemulsification, CME
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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
Key inclusion criteria (4 listed)
- patients undergoing cataract surgery
- minimum age 18 years
- phacoemulsification technique
- subsequent implantation of a monofocal hydrophobic acrylic intraocular lens
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vitreous hyperreflective dots
Time frame: preoperatively until 3 months postoperatively
Change of correlation between occurrence of vitreous hyperreflective dots and the macular thickness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystoid Macular Edema Following Cataract Surgery and Vitreous Hyperreflective Dots, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitreous hyperreflective dots (time frame: preoperatively until 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.