55
Participants
Start Date
July 31, 2003
Primary Completion Date
April 30, 2009
Study Completion Date
May 31, 2009
Punctal plugs, punctal cautery
25 subjects(20 silicone punctal plugs, 5 punctal cautery) The procedure will be based on clinical indication. Randomized one eye for study. Baseline cultures of lid margin \& tarsal/inferior fornix conjunctiva obtained \& plated according to protocol
Punctal Plug, Punctal thermocauterization
"Up to 5 subjects. Subjects in need of punctal occlusion(No preference for punctal thermocauterization or punctal occlusion by silicone plug). Randomize one eye to silicone punctal plug occlusion, the other eye to punctal thermocauterization.~This group ONLY, cultures will be obtained of the lid margin \& conjunctiva/inferior fornix of BOTH eyes"
Silicone plug or thermodynamic hydrophobic acrylic plug
"Up to 5 subjects. Subjects in need of punctal occlusion(not preference for punctal occlusion by silicone plug or by the thermodynamic hydrophobic acrylic plug). Randomize one eye to silicone punctal plug occlusion, the other eye to acrylic punctal plug occlusion.~In this group ONLY cultures will be obtained of the lid margin and conjunctiva/inferior fornix of BOTH eyes"
Previous subjects with Punctal occlusion
"Up to 20 subjects(15 subjects with silicone punctal plug closure and 5 subjects with punctal closure by thermocauterization)Subjects who have previously had punctal occlusion who have symptoms and/or signs thought to be secondary to punctal occlusion.~Lid margin and conjunctiva/inferior fornix of eye with greatest sign or symptoms will be cultured/plated according to standard protocol."
Lahey Clinic, Inc., Burlington
Lahey Clinic North, Peabody
Lead Sponsor
Lahey Clinic
OTHER