NCT06358664

Brief Summary

Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

April 4, 2024

Last Update Submit

April 10, 2024

Conditions

Cataract

Keywords

Pars plana vitrectomyCaffeineRetinal detachmentMacular Pucker

Outcome Measures

Primary Outcomes (1)

  • Significant cataract formation at year 1

    Frequency of significant cataract formation one year after vitrectomy in study eyes as compared to control eyes

    12 months

Secondary Outcomes (2)

  • Significant cataract formation at month 6

    12 months

  • Distance corrected visual acuity (DCVA)

    12 months

Study Arms (2)

Caffeine consumption

EXPERIMENTAL

Patients with regular caffeine consumption needing pars plana vitrectomy

Procedure: Pars plana vitrectomy

No caffeine consumption

EXPERIMENTAL

Patients with regular caffeine consumption needing pars plana vitrectomy

Procedure: Pars plana vitrectomy

Interventions

Pars plana vitrectomyPROCEDURE

Standard pars plana vitrectomy will be performed

Caffeine consumptionNo caffeine consumption

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Written informed consent
  • No previous cataract surgery in the study eye
  • Scheduled small gauge vitrectomy with intraoperative gas tamponade (SF6 or C3F8) due to retinal detachment or macular hole repair
  • No regular caffeine consumption (drinking not more than one cup of a caffeine- containing beverage \[e.g. coffee, energy drinks\] at a maximum of two days per week during the past year)

You may not qualify if:

  • Intake of systemic or topical corticosteroids within 3 months before study screening
  • Increased risk for postoperative cataract development, for example due to ocular trauma in the history
  • Severe cataract (LOCS III grading of any cataract form \>2) in the study eye at pre- study screening
  • Scheduled phacovitrectomy in the study eye
  • Participation in any clinical trial three month before study screening
  • Ocular surgeries six month before study screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

CataractRetinal DetachmentEpiretinal Membrane

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRetinal Diseases

Study Officials

  • Oliver Findl, Prim. Dr.

    Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Schlatter, MD

CONTACT

+4391021office@viros.at

Christoph Leisser, DDr.

CONTACT

+4391021office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)