Following message received form Medjet Inc., USA is posted here for your attention (we have no commercial interest the device being talked about):
Dear Ophthalmologist, Pterygium is an ocular disorder, common in tropical and subtropical areas, which results from a combination of corneal surface drying and actinic exposure from the sun. Despite the description of more than 100 medical and surgical techniques, surgical removal is still complicated by two factors, the high recurrence rate and the postoperative persistence of dryness and irritation. We believe our innovative water-jet surgical device could improve pterygium surgical removal outcomes. Our first product, the HydroBrush Keratome, has just been cleared for marketing by the US Food and Drug Administration. This hand-held water-jet keratome is designed for epithelial debridement, a preliminary step in Photo Refractive Keratoplasty. The HydroBrush Keratome removes the epithelium of the cornea, in an area of 7-8 mm in diameter in 6 seconds, without damage to the underlying Bowman's layer and basement membrane. We are now investigating the use of our HydroBrush Keratome as a simple and quick cleaving device for pterygium surgical removal. To get a better understanding of the pterygium, its prevalence and clinical issues, and to develop a product corresponding to your needs, we are conducting a survey of more than 2000 ophthalmologists throughout the world. Of course, we will send you the results of the survey if you are interested. In addition, if we succeed in collecting enough information, the results will be published so that the entire ophthalmologic community can benefit from this work. Medjet is a publicly traded, development-stage company developing cutting and debriding devices for corneal surgery based on proprietary MicroJet technology. Thank you in advance for your time and cooperation. We are looking forward to hearing from you. Sincerely Yours, Gernot Richter, MD, Clinical Director Barbara Parolini, MD, Clinical Advisor Enclosed is the questionnaire that should take you 5 minutes to complete. Please, return the questionnaire to us by e-mail. You can also send it by fax or mail. Medjet Inc. 1090 King Georges Post Road, Suite 301, Edison, NJ 08837, USA Phone : (1) 732-738 -3990 Fax : (1) 732-738-3984 MEDJET@worldnet.att.net PTERYGIUM QUESTIONNAIRE Please fill out all the questionnaire either with single or multiple answers (SA,MA) by inserting an X in ( ) 1. How many pterygia do you diagnose every year ? SA ( ) < 100 ( ) 100-300 ( ) > 300 Give a number if available : 2. Compared to the cases of pterygia you diagnose, what percentage do you remove every year ? SA ( ) < 10 % ( ) 10-25 % ( ) 25-50 % ( ) 50-75 % ( ) > 75 % Give the number of pterygium surgeries you perform every year if available : 3. What are the 1st, the 2nd and the 3rd most important issues that bring your patients to request surgical removal ? The 1st most important issue (Single Answer) ( ) Vision disturbance ( ) Inability to wear contact lenses ( ) Cosmetic issue ( ) Irritation or chronic inflammation ( ) Other : The 2nd most important issue (Single Answer) ( ) Vision disturbance ( ) Inability to wear contact lenses ( ) Cosmetic issue ( ) Irritation or chronic inflammation ( ) Other : The 3rd most important issue (Single Answer) ( ) Vision disturbance ( ) Inability to wear contact lenses ( ) Cosmetic issue ( ) Irritation or chronic inflammation ( ) Other : 4. Is the rate of surgical removal in your practice growing ? SA ( ) Yes (Go to question 5) ( ) No, it is stable (Go directly to question 7) ( ) No, on the contrary, it has decreased (Go directly to 6) 5. If yes, what is the most likely reason for this increase ? MA ( ) More confidence in surgical technique ( ) More frequent use of contact lenses ( ) The prevalence of pterygium has grown ( ) Other : 6. If no, what is the most likely reason for this decrease ? MA ( ) Pterygium is not an important concern for my patients ( ) The surgical procedure is not adequate ( ) The recurrence rate is still too high ( ) Other : 7. What mode of anesthesia are you using most often ? SA ( ) Retrobulbar injection ( ) Topical administration ( ) Subconjunctival injection ( ) Other : 8. How long does the average removal procedure take without anesthesia and any complementary treatment ? ( ) < 10 min ( ) 10-15 min ( ) > 15 min 9. What are the 1st, the 2nd and the 3rd most important drawbacks of your surgical technique, if there are any ? The 1st most important drawback (Check only 1 item) ( ) Time consuming ( ) Intra-operative complications: corneal thinning, globe perforation, etc … ( ) Rough sclera and corneal surface ( ) High recurrence rate ( ) Others : The 2nd most important drawback (Check only 1 item) ( ) Time consuming ( ) Intra-operative complications: corneal thinning, globe perforation, etc … ( ) Rough sclera and corneal surface ( ) High recurrence rate ( ) Others : The 3rd most important drawback (Check only 1 item) ( ) Time consuming ( ) Intra-operative complications: corneal thinning, globe perforation, etc … ( ) Rough sclera and corneal surface ( ) High recurrence rate ( ) Others : 10. What is the recurrence rate you observe without any complementary treatment ? SA ( ) < 10 % ( ) 10-30 % ( ) 30-50 % ( ) > 50 % 11. If there is recurrence and a re-operation is performed, how long is the time between the 1st and 2nd surgical removal ? SA ( ) < 3 months ( ) 3 months - 1 year ( ) > 1 year 12. What in your experience best characterizes the recurrent pterygium? MA ( ) Bigger and more firmly attached than the precedent ( ) Grows faster than the precedent ( ) Identical to the precedent ( ) Other : 13. What in your experience are the limitations to repeat surgery on the same eye ? MA ( ) Existing scarring ( ) Corneal thinning ( ) Increasing chance for recurrence ( ) Patients refuse further procedures ( ) Low patient cost acceptance ( ) Other : 14. What percentage of your patients need corneal transplantation as a result of unsuccessful pterygium removal surgeries? 15. Do you perform any additional treatment to decrease the recurrence rate ? ( ) Yes (Go to question 16) ( ) No (Go to directly to question 18) 16. If yes, what additional treatments do you most frequently choose to reduce the recurrence rate ? The 1st most frequent additional treatment (Check only 1 item) ( ) Conjunctival transplant ( ) Tenon's capsule removal at the border of pterygium dissection ( ) Mitomycin C ( ) Beta irradiation ( ) A combination of treatments : ( ) Other : The 2nd most frequent additional treatment (Check only 1 item) ( ) Conjunctival transplant ( ) Tenon's capsule removal at the border of pterygium dissection ( ) Mitomycin C ( ) Beta irradiation ( ) A combination of treatments : ( ) Others : The 3rd most frequent additional treatment (Check only 1 item) ( ) Conjunctival transplant ( ) Tenon's capsule removal at the border of pterygium dissection ( ) Mitomycin C ( ) Beta irradiation ( ) A combination of treatments : ( ) Others : 17. What is the recurrence rate you observe with your best procedure ? SA ( ) < 10 % ( ) 10-30 % ( ) > 30 % 18. How do you characterize the cosmetic outcome in most of your patients with the surgical technique you follow? SA ( ) Terrible ( ) Acceptable ( ) Very good 19. Do you use excimer laser in pterygium surgery ? SA ( ) Yes ( ) No (Go directly to question 22) 20. If yes, what are its purposes ? MA ( ) To decrease the recurrence rate ( ) To smooth the surface ( ) To remove scars ( ) Other : 21. What percentage of patients do you treat with laser ? 22. What would be the 1st, the 2nd and the 3rd most important improvements in pterygium surgery and its outcome ? The 1st most important improvement (Check only 1 item) ( ) A low recurrence rate ( ) A fast and easy procedure ( ) A smooth surface for a better cosmetic result ( ) A smooth surface for faster healing ( ) A smooth surface to avoid astigmatism ( ) Other : The 2nd most important improvement (Check only 1 item) ( ) A low recurrence rate ( ) A fast and easy procedure ( ) A smooth surface for a better cosmetic result ( ) A smooth surface for faster healing ( ) A smooth surface to avoid astigmatism ( ) Other : The 3rd most important improvement (Check only 1 item) ( ) A low recurrence rate ( ) A fast and easy procedure ( ) A smooth surface for a better cosmetic result ( ) A smooth surface for faster healing ( ) A smooth surface to avoid astigmatism ( ) Other : 23. If you could remove pterygium in less than 20 seconds and leave a smooth cornea and sclera, without decreasing the recurrence rate, would you characterize it as ? SA ( ) Important ( ) Not Important 24. Please, indicate the average price of the pterygium removal surgery in your local currency or in US dollar ? Local Currency : US $ : 25. Do you have any other comments on pterygium removal ? 26. Please indicate your specialty if any ( ) Corneal/Anterior segment Surgery ( ) Cataract/IOL/Refractive Surgery ( ) Others : 27. Are you interested in receiving ( ) More material on our technology ( ) The results of this study. 28. If yes, please indicate your Name Affiliation Adress City Zip Code Country Phone Fax 29. Otherwise, indicate at least the country and the city where you are working
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