CataractNCT06358664
Caffeine and Cataract After Pars Plana Vitrectomy
A study testing Pars plana vitrectomy in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2024to 1 Apr 2026
- Phase
- Interventional
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna
Vienna, 1140
Andreas Schlatter, MD, +4391021 ext. 57564, office@viros.at
Christoph Leisser, MMD, +4391021 ext. 57564, office@viros.at
About this study
Official title: The Effect of Caffeine Consumption on Cataract Formation After Pars Plana Vitrectomy: a Comparative Study
Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy.
Read the detailed description
Vitrectomy is a frequently used surgical procedure in ophthalmology for various indications like retinal detachment repair or macular pucker peeling. Amongst others, accelerated cataract development in phakic patients is a known complication after vitrectomy. A previous study found that especially patients receiving gas tamponade are at increased risk for postoperative cataract development. The assumed mechanism behind this finding is that vitrectomy leads to an increased partial pressure of O2 in the human vitreous - similar to that observed in posterior vitreous detachment - subsequently leading to accelerated lens opacification. Therefore, a possible target of cataract prevention is the inhibition of oxygen radical formation. One known antioxidant agent inhibiting oxygen radical formation is caffeine. For instance, in-vitro studies showed that caffeine consumption can reduce cataract development in ultraviolet (UV)-radiation-exposed rats and human lens epithelial cells through its capability of inhibiting oxygen radical formation. These in-vitro studies support the findings of epidemiological studies that caffeine also in-vivo has the potential to reduce cataractogenesis. Conflating the previous findings of accelerated cataract formation after vitrectomy and the preventive properties of caffeine for cataract development, there may be a benefit for patients regularly consuming caffeine-containing beverages like coffee undergoing vitrectomy regarding postoperative cataract formation.
Therefore, the aim of this comparative study is to investigate if patients undergoing small gauge pars plana vitrectomy regularly consuming caffeine have lower postoperative significant cataract formation rates than patients not consuming caffeine.
- Conditions
- Cataract
- Being tested
- Pars plana vitrectomy
- Keywords
- Pars plana vitrectomy, Caffeine, Retinal detachment, Macular Pucker
- Medical subject headings
- Cataract, Retinal Detachment, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomyProcedure or surgery
Standard pars plana vitrectomy will be performed
| Study group | Role | What they receive |
|---|---|---|
| Caffeine consumption | Experimental | Patients with regular caffeine consumption needing pars plana vitrectomy Receives: Procedure: Pars plana vitrectomy |
| No caffeine consumption | Experimental | Patients with regular caffeine consumption needing pars plana vitrectomy Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant cataract formation at year 1
Frequency of significant cataract formation one year after vitrectomy in study eyes as compared to control eyes
Measured: 12 months
Secondary outcomes (2)
Significant cataract formation at month 6
Frequency of significant cataract formation 6 months after vitrectomy in study eyes as compared to control eyes
Measured: 12 months
Distance corrected visual acuity (DCVA)
DCVA at all study visits in study eyes as compared to control eyes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prim. Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358664
- Sponsor's protocol ID
- Caffeine Vitrectomy
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caffeine Consumption on Cataract Formation After Pars Plana Vitrectomy: a Comparative Study
- ClinicalTrials.gov ID
- NCT06358664
- Acronym / sponsor ID
- Caffeine Vitrectomy
- Conditions
- Cataract
- Keywords
- Pars plana vitrectomy, Caffeine, Retinal detachment, Macular Pucker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 10 Apr 2024 (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.
Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy.
Detailed description
Vitrectomy is a frequently used surgical procedure in ophthalmology for various indications like retinal detachment repair or macular pucker peeling. Amongst others, accelerated cataract development in phakic patients is a known complication after vitrectomy. A previous study found that especially patients receiving gas tamponade are at increased risk for postoperative cataract development. The assumed mechanism behind this finding is that vitrectomy leads to an increased partial pressure of O2 in the human vitreous - similar to that observed in posterior vitreous detachment - subsequently leading to accelerated lens opacification. Therefore, a possible target of cataract prevention is the inhibition of oxygen radical formation. One known antioxidant agent inhibiting oxygen radical formation is caffeine. For instance, in-vitro studies showed that caffeine consumption can reduce cataract development in ultraviolet (UV)-radiation-exposed rats and human lens epithelial cells through its capability of inhibiting oxygen radical formation. These in-vitro studies support the findings of epidemiological studies that caffeine also in-vivo has the potential to reduce cataractogenesis. Conflating the previous findings of accelerated cataract formation after vitrectomy and the preventive properties of caffeine for cataract development, there may be a benefit for patients regularly consuming caffeine-containing beverages like coffee undergoing vitrectomy regarding postoperative cataract formation.
Therefore, the aim of this comparative study is to investigate if patients undergoing small gauge pars plana vitrectomy regularly consuming caffeine have lower postoperative significant cataract formation rates than patients not consuming caffeine.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine consumption | Experimental | Procedure: Pars plana vitrectomyPatients with regular caffeine consumption needing pars plana vitrectomy |
| No caffeine consumption | Experimental | Procedure: Pars plana vitrectomyPatients with regular caffeine consumption needing pars plana vitrectomy |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pars plana vitrectomyStandard pars plana vitrectomy will be performed | Procedure or surgery | Caffeine consumption, No caffeine consumption |
Primary outcome
Significant cataract formation at year 1
Time frame: 12 months
Frequency of significant cataract formation one year after vitrectomy in study eyes as compared to control eyes
2 secondary outcomes
Significant cataract formation at month 6
Time frame: 12 months
Distance corrected visual acuity (DCVA)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Oliver Findl, Prim. Dr. principal investigator
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars plana vitrectomy in people with Cataract, run by Vienna Institute for Research in Ocular Surgery 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Schlatter, MD (+4391021 ext. 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant cataract formation at year 1 (time frame: 12 months). 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 12 Apr 2024.