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Caffeine and Cataract After Pars Plana Vitrectomy

V

Vienna Institute for Research in Ocular Surgery

Status

Enrolling

Conditions

Cataract

Treatments

Procedure: Pars plana vitrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06358664
Caffeine Vitrectomy

Details and patient eligibility

About

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

Full 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.

Enrollment

74 estimated patients

Sex

All

Ages

18 to 105 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

Caffeine consumption
Experimental group
Description:
Patients with regular caffeine consumption needing pars plana vitrectomy
Treatment:
Procedure: Pars plana vitrectomy
No caffeine consumption
Experimental group
Description:
Patients with regular caffeine consumption needing pars plana vitrectomy
Treatment:
Procedure: Pars plana vitrectomy

Trial contacts and locations

1

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Central trial contact

Christoph Leisser, DDr.; Andreas Schlatter, MD

Data sourced from clinicaltrials.gov

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