An interventional study of Pars plana vitrectomy in Cataract, sponsored by Vienna Institute for Research in Ocular Surgery. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 105 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Basic science
Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy.
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 74 is close to the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with regular caffeine consumption needing pars plana vitrectomy
Procedure: Pars plana vitrectomy
Patients with regular caffeine consumption needing pars plana vitrectomy
Procedure: Pars plana vitrectomy
Standard pars plana vitrectomy will be performed
Significant cataract formation at year 1
Frequency of significant cataract formation one year after vitrectomy in study eyes as compared to control eyes
Time frame: 12 months
Significant cataract formation at month 6
Frequency of significant cataract formation 6 months after vitrectomy in study eyes as compared to control eyes
Time frame: 12 months
Distance corrected visual acuity (DCVA)
DCVA at all study visits in study eyes as compared to control eyes
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Apr 2026, 24 months after the start.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 24 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
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Vienna Institute for Research in Ocular Surgery