PURPOSE: To evaluate experimentally and clinically the tolerance and efficacy of a reticulated hyaluronic acid implant in nonperforating trabecular surgery (NPTS). SETTING: Bascom Palmer Eye Institute, Miami, Florida, USA, and Clinique Sourdille and Clinique Ophtalmologique Universitaire, Nantes, France. METHODS: In experimental surgery, NPTS was performed with and without a hyaluronic acid implant in 25 rabbit eyes. In a pilot study, the results of NPTS with a hyaluronic acid implant in 72 human eyes were retrospectively analyzed in terms of visual acuity, intraocular pressure (IOP), external filtration, postoperative inflammation, and gonioscopy. Mean follow-up was 13.8 months (range 6 to 24 months). RESULTS: In the experimental surgery, the rabbit eyes with the implant showed a different healing process than the eyes without the implant. The implant was slowly bioabsorbed and remnants were seen at the operative site (where the tissue was removed) up to day 56 postoperatively. This site was detectable at all histology study periods. Intraocular pressure reduction was longer in the implant group: greater than 5 months versus 3 weeks (P < .05). In the pilot study, visual acuity remained stable, IOP decreased from a mean preoperative level of 26.3 mm Hg +/- 5.22 (SD) to a mean postoperative level without treatment of 15.4 +/- 3.1 mm Hg (P < .0001). No external filtration was detected in 60 eyes, a slightly elevated conjunctiva was noted in 12 eyes. Postoperative inflammation (laser flare and cell measurements) was low. Gonioscopy consistently demonstrated the persistence of a decompression space behind the trabeculum. CONCLUSION: Comparative experimental surgery results showed excellent tolerance and efficacy in the rabbit eyes with a hyaluronic acid implant. Clinical results, to be confirmed by a randomized comparative study, also showed excellent biocompatibility and encouraging efficacy.
PURPOSE: To evaluate experimentally and clinically the tolerance and efficacy of a reticulated hyaluronic acid implant in nonperforating trabecular surgery (NPTS). SETTING: Bascom Palmer Eye Institute, Miami, Florida, USA, and Clinique Sourdille and Clinique Ophtalmologique Universitaire, Nantes, France. METHODS: In experimental surgery, NPTS was performed with and without a hyaluronic acid implant in 25 rabbit eyes. In a pilot study, the results of NPTS with a hyaluronic acid implant in 72 human eyes were retrospectively analyzed in terms of visual acuity, intraocular pressure (IOP), external filtration, postoperative inflammation, and gonioscopy. Mean follow-up was 13.8 months (range 6 to 24 months). RESULTS: In the experimental surgery, the rabbit eyes with the implant showed a different healing process than the eyes without the implant. The implant was slowly bioabsorbed and remnants were seen at the operative site (where the tissue was removed) up to day 56 postoperatively. This site was detectable at all histology study periods. Intraocular pressure reduction was longer in the implant group: greater than 5 months versus 3 weeks (P < .05). In the pilot study, visual acuity remained stable, IOP decreased from a mean preoperative level of 26.3 mm Hg +/- 5.22 (SD) to a mean postoperative level without treatment of 15.4 +/- 3.1 mm Hg (P < .0001). No external filtration was detected in 60 eyes, a slightly elevated conjunctiva was noted in 12 eyes. Postoperative inflammation (laser flare and cell measurements) was low. Gonioscopy consistently demonstrated the persistence of a decompression space behind the trabeculum. CONCLUSION: Comparative experimental surgery results showed excellent tolerance and efficacy in the rabbit eyes with a hyaluronic acid implant. Clinical results, to be confirmed by a randomized comparative study, also showed excellent biocompatibility and encouraging efficacy.
Authors: Fernando Galassi; Barbara Giambene; Andrea Corvi; Giacomo Falaschi; Ugo Menchini Journal: Int Ophthalmol Date: 2007-10-19 Impact factor: 2.031