Caffeine and Cataract After Pars Plana Vitrectomy

NCT06358664 — Not applicable, Unknown, 74 participants, Vienna Institute for Research in Ocular Surgery

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

RegistryNCT06358664
StatusUnknown
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, basic science
Enrollment74 (Estimated)
SponsorVienna Institute for Research in Ocular Surgery (Other)
ConditionsCataract
InterventionsPars plana vitrectomy (Procedure)
Datesstart 2024-04-01, primary completion 2026-04-01 (estimated), completion 2026-04-01 (estimated), first posted 2024-04-10, last updated 2024-04-12
Locations1 site in Austria

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All trials for Cataract All trials of Pars plana vitrectomy

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Caffeine consumptionExperimentalProcedure: Pars plana vitrectomyPatients with regular caffeine consumption needing pars plana vitrectomy
No caffeine consumptionExperimentalProcedure: Pars plana vitrectomyPatients with regular caffeine consumption needing pars plana vitrectomy
  • Pars plana vitrectomy (Procedure): Standard pars plana vitrectomy will be performed

+Outcome measures

Primary outcomes

  • Significant cataract formation at year 1 [12 months]: Frequency of significant cataract formation one year after vitrectomy in study eyes as compared to control eyes

Secondary outcomes

  • Significant cataract formation at month 6 [12 months]: Frequency of significant cataract formation 6 months after vitrectomy in study eyes as compared to control eyes
  • Distance corrected visual acuity (DCVA) [12 months]: DCVA at all study visits in study eyes as compared to control eyes

+Eligibility

Sex: All, ages: 18 Years to 105 Years

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

+Locations (1)

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

+Investigators

  • Oliver Findl, Prim. Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus