Caffeine and Cataract After Pars Plana Vitrectomy

NCT ID: NCT06358664

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-04-01

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.

Conditions

Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Caffeine consumption

Patients with regular caffeine consumption needing pars plana vitrectomy

Group Type: EXPERIMENTAL

Pars plana vitrectomy

Intervention Type: PROCEDURE

Standard pars plana vitrectomy will be performed

No caffeine consumption

Patients with regular caffeine consumption needing pars plana vitrectomy

Group Type: EXPERIMENTAL

Pars plana vitrectomy

Intervention Type: PROCEDURE

Standard pars plana vitrectomy will be performed

Interventions

Pars plana vitrectomy

Standard pars plana vitrectomy will be performed

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Findl, Prim. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus

Locations

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

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Andreas Schlatter, MD

Role: CONTACT

office@viros.at

+4391021 ext. 57564

Christoph Leisser, DDr.

Role: CONTACT

office@viros.at

+4391021 ext. 57564

Facility Contacts

Andreas Schlatter, MD

Role: primary

office@viros.at

+4391021 ext. 57564

Christoph Leisser, MMD

Role: backup

office@viros.at

+4391021 ext. 57564

Other Identifiers

Caffeine Vitrectomy

Identifier Type: -

Identifier Source: org_study_id