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Vol. 216, No. 6, 2002
Issue release date: November–December 2002

Effects of Sildenafil Citrate (Viagra) on Choroidal Congestion

McCulley T.J. · Luu J.K. · Marmor M.F. · Feuer W.J.
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Abstract

This study evaluates the effect of sildenafil on choroidal vascular congestion and its correlation with visual effects. Thirteen healthy subjects were randomized to a sildenafil group (n = 7, 3 M, 4 F), who received 200 mg of sildenafil, and a control (n = 6, 5 F, 1 M) group, who received no drug. Measurements of choroidal thickness with ultrasonography, color vision with Desaturated Panel D-15 Test, and contrast sensitivity with CSV-1000e charts (Vector Vision) were performed at baseline and at 90 and 180 min. Mean choroidal thickness and contrast sensitivity did not change significantly relative to baseline in either group. However, the variance in differences between repeat and baseline measurements of choroidal thickness was significantly higher at 90 min (p = 0.003) in the sildenafil subjects. Color discrimination error scores increased after sildenafil but did not correlate with changes in choroidal thickness. An oral dose of 200 mg of sildenafil caused small inconsistent changes in choroidal thickness, which did not correlate with visual effects.



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References

  1. Food and Drug Administration (FDA a) Joint Clinical Review. Study 101/101B: A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, multicenter, long-term dose-response study to assess the efficacy and safety of sildenafil (UK-92, 480) administered prior to sexual activity to male patients with erectile dysfunction, pp 99–102.
  2. Food and Drug Administration (FDA b) Joint Clinical Review. Study 148-102: A double-blind, randomized, placebo controlled, parallel-group, fixed-dose, multicenter, study to assess the efficacy and safety of UK-92, 480 administered over six months to male patients with erectile dysfunction, pp 104–110.
  3. Food and Drug Administration (FDA c) Joint Clinical Review. Study 148-103: A double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible dose escalation study to assess the efficacy and safety of sildenafil administered as required to male patients with erectile dysfunction, pp 111–117.
  4. Utinger RD: A pill for impotence: N Engl J Med 1998;338:148–149.
  5. Wallis RM, Corbin JD, Francis SH, Ellis P: Tissue distribution of phosphodiesterase families and the effects of sildenafil on tissue cyclic nucleotides, platelet function, and the contractile responses of trabeculae carneae and aortic rings in vitro. Am J Cardiol 1999;83:3C–12C.

    External Resources

  6. Food and Drug Administration (FDA d) Joint Clinical Review. Study 148-004: Phase 1 investigator-blind, placebo-controlled evaluation of safety, toleration, and pharmacokinetics of sildenafil following escalating single oral doses in healthy male volunteers, pp 96–98.
  7. Food and Drug Administration (FDA e) Joint Clinical Review. Study 148-228: An open, randomized, single oral dose, four way crossover study to determine the dose proportionality of the pharmacokinetics of sildenafil in healthy male volunteers over the dose range 15 mg to 200 mg, pp 167–169.
  8. Zusman RM, Morales A, Glasser DB, Osteroh IH: Overall cardiovascular profile of sildenafil citrate. Am J Cardiol 1999;83:35C–44C.

    External Resources

  9. Food and Drug Administration (FDA f) Joint Clinical Review. Study 148-223: An open, randomized, placebo-controlled, four period crossover study to assess the effect of orally administered sildenafil (50, 100 and 200 mg) on visual function in healthy male volunteers, pp 160–161.
  10. Food and Drug Administration (FDA g) Review and Evaluation of Pharmacology and Toxicology Data. Section 1.2.3.6 Pharmacology: Activities related to mechanism of action: Functional effects on other tissues expressing PDE5 enzyme: Retinal effects, 1998, pp 19–21.
  11. Marmor MF, Kessler R: Sildenafil (Viagra) and ophthalmology. Sur Ophthalmol 1999;44(2):153–162.
  12. Siu K, Grunwald JE, Jacob SS, Dupont J: Effect of Viagra on ocular circulation. Invest Ophthalmol Vis Sci 2000;41(suppl):S98.
  13. Food and Drug Administration (FDA h) Joint Clinical Review. Animal pharmacology: Mechanism of action, p 4.
  14. Sponsel WE, Sandoval S, Chen N, DuPont J: Effects of sildenafil (Viagra) on ocular blood perfusion and contrast sensitivity. Invest Ophthalmol Vis Sci 2000;41(suppl):S98.
  15. Food and Drug Administration (FDA i) Joint Clinical Review. Study 148-232: A randomized, double-blind, placebo-controlled, crossover pilot study to investigate the effects of a single oral table dose of sildenafil (200 mg) on visual function (electroretinogram) in healthy male volunteers and patients with diabetic retinopathy.
  16. Grunwald JE, Koppiker NP, Hodges M: Visual adverse events in patients with eye disorders who received sildenafil for the treatment of erectile dysfunction. Invest Ophthalmol Vis Sci 1999;40(suppl):S767.


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