NCT03534973

Brief Summary

Investigate if caffeine accumulation in human lens epithelial cells after oral caffeine intake is sufficient to prevent from experimental ultraviolet radiation induced apoptosis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

April 17, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

1.6 years

First QC Date

April 30, 2018

Last Update Submit

October 1, 2019

Conditions

Cataract

Keywords

CataractCaffeine

Outcome Measures

Primary Outcomes (1)

  • Number of apoptotic and viable lens epithelial cells from eyes with and without oral caffeine intake

    Using a cell apoptosis and viability assay the number of apoptotic and viable lens epithelial cells is counted under a fluorescence microscope

    12 months

Study Arms (2)

Caffeine intake

ACTIVE COMPARATOR

Caffeine is given orally prior to cataract surgery

Other: Caffeine intake

No caffeine intake

SHAM COMPARATOR

Caffeine is not given orally prior to cataract surgery

Other: No caffeine intake

Interventions

Caffeine intakeOTHER

Cataract surgery in eyes with prior caffeine intake

Caffeine intake
No caffeine intakeOTHER

Cataract surgery in eyes without prior caffeine intake

No caffeine intake

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 21 years
  • Cataract
  • Patients who chose pseudoanalgesia technique for cataract surgery before recruitment process
  • Written informed consent prior to surgery

You may not qualify if:

  • Age \< 21 years
  • Beverages containing caffeine (such as Coffee, Coca Cola, energy drinks, black or green tea) and dark chocolate consumption 1 week before surgery
  • Pseudoexfoliation syndrome of the lens
  • Systolic hypertension of \>160 at the day of surgery
  • Pregnancy (pregnancy test will be taken in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Martin Kronschlaeger, MD

CONTACT

01 91021-57572martin.kronschlaeger@gmx.at

Manuel Ruiß, MSc

CONTACT

01 91021-57564m.ruiss@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 23, 2018

Study Start

April 17, 2018

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

October 2, 2019

Record last verified: 2019-10

Locations

AU(1)