A Phase 1 interventional study of Hydroxybutyl chitosan and 5-Fluorouracil in Dacryocystorhinostomy, Hydroxybutyl Chitosan and Fluorouracil, sponsored by Tianjin Medical University Eye Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Tianjin Medical University Eye Hospital · Phase 1, Interventional, and Treatment
Endoscopic dacryocystorhinostomy (En-DCR) has the advantages of less surgical trauma, shorter time, less postoperative bleeding, faster recovery, and no skin scars. However, the success rate of En-DCR surgery still varies greatly between 58% and 94% , and the main reason for the failure of the surgery is the membranous closure of the anastomosis. The application of new packing materials in dacryocystorhinostomy provides some new ways to improve the success rate of En-DCR.
Hydroxybutyl chitosan (HBCS), with its non-toxicity, biocompatibility, biodegradability, antibacterial, moisturizing properties, water solubility and temperature sensitivity, is widely used in biomedicine to prevent postoperative adhesions.
5-Fluorouracil (5-FU) is an antimetabolite drug that is effective in the treatment of keloids. The application of 5-FU in glaucoma filtration surgery has demonstrated its good safety and efficacy. Studies have shown that antimetabolites as adjuvant therapy for DCR have a positive impact on improving the success rate of surgery In this study, thermosensitive hydroxybutyl chitosan will be applied to the anastomosis site of the nasal mucosal flap and the lacrimal mucosal flap, or 0.3ml of 5-fluorouracil solution (25mg/ml) was injected into the nasal mucosa around the anastomosis at the same time. The investigators would like to observe the different situations of clinical symptoms, lacrimal duct flushing, endoscopy, and bacterial flora changes in patients with chronic dacryocystitis, to compare them with the previous intraoperative packing of gelatin sponge wrapped with thrombin and Tobramycin Dexamethasone. Furthermore, the investigators intend to evaluate the safety and efficacy of HBCS and 5-FU adjuvant internal En-DCR in the treatment of chronic dacryocystitis, and provide new ideas for the adjuvant therapy of En-DCR.
Endoscopic dacryocystorhinostomy (En-DCR) has the advantages of less surgical trauma, shorter time, less postoperative bleeding, faster recovery, and no skin scars. However, the success rate of En-DCR surgery still varies greatly between 58% and 94% , and the main reason for the failure of the surgery is the membranous closure of the anastomosis. The application of new packing materials in dacryocystorhinostomy provides some new ways to improve the success rate of En-DCR.
Hydroxybutyl chitosan (HBCS), with its non-toxicity, biocompatibility, biodegradability, antibacterial, moisturizing properties, water solubility and temperature sensitivity, is widely used in biomedicine to prevent postoperative adhesions.
5-Fluorouracil (5-FU) is an antimetabolite drug that is effective in the treatment of keloids. The application of 5-FU in glaucoma filtration surgery has demonstrated its good safety and efficacy. Studies have shown that antimetabolites as adjuvant therapy for DCR have a positive impact on improving the success rate of surgery In this study, thermosensitive hydroxybutyl chitosan will be applied to the anastomosis site of the nasal mucosal flap and the lacrimal mucosal flap, or 0.3ml of 5-fluorouracil solution (25mg/ml) was injected into the nasal mucosa around the anastomosis at the same time. The investigators would like to observe the different situations of clinical symptoms, lacrimal duct flushing, endoscopy, and bacterial flora changes in patients with chronic dacryocystitis, to compare them with the previous intraoperative packing of gelatin sponge wrapped with thrombin and Tobramycin Dexamethasone. Furthermore, the investigators intend to evaluate the safety and efficacy of HBCS and 5-FU adjuvant internal En-DCR in the treatment of chronic dacryocystitis, and provide new ideas for the adjuvant therapy of En-DCR.
Tianjin Medical University Eye Hospital is the lead sponsor of 18 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Apply HBCS to the anastomosis of the nasal mucosal flap and the dacryocyst mucosal flap
Drug: Hydroxybutyl chitosan
Inject 0.3ml of 5-FU solution (25mg/ml) into the nasal mucosa around the anastomosis, and apply HBCS to the anastomosis of the nasal mucosal flap and the dacryocyst mucosal flap
Drug: Hydroxybutyl chitosan · Drug: 5-Fluorouracil
Apply gelatin sponge sheet covered with thrombin and tobramycin and dexamethasone ophthalmic ointment to the anastomosis of nasal mucosal flap and dacryocyst mucosal flap
Drug: Gelatin Sponge Sheet
Apply HBCS to the anastomosis of the nasal mucosal flap and the dacryocyst mucosal flap
Inject 0.3ml of 5-FU solution (25mg/ml) into the nasal mucosa around the anastomosis, and apply HBCS to the anastomosis of the nasal mucosal flap and the dacryocyst mucosal flap
Apply gelatin sponge sheet covered with thrombin and tobramycin and dexamethasone ophthalmic ointment to the anastomosis of nasal mucosal flap and dacryocyst mucosal flap
Clinical symptoms
postoperative comfort and bleeding, and epiphora using score sheets
Time frame: six moths
Lacrimal duct flushing
Check for patency of the lacrimal drainage
Time frame: six moths
Endoscopic examination
anastomotic areas(the lengths of the long and short axes), scarring and adhesions, and granulation
Time frame: six moths
Bacterial flora changes
conjunctival sac, nasal mucosa
Time frame: two moths
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Dacryocystitis
Tianjin Medical University Eye Hospital