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Clinical Trials/NCT06358664
NCT06358664UnknownNot Applicable

The Effect of Caffeine Consumption on Cataract Formation After Pars Plana Vitrectomy: a Comparative Study

Vienna Institute for Research in Ocular Surgery2 sites in 1 country74 target enrollmentStarted: April 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
74
Locations
2
Primary Endpoint
Significant cataract formation at year 1

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 105 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Distance corrected visual acuity (DCVA)(12 months)
  • Significant cataract formation at month 6(12 months)

Investigators

Sponsor
Vienna Institute for Research in Ocular Surgery
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

Study Sites (2)

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