Alex Malandrini1, Gianluca Martone2, Annalisa Canovetti2, Luca Menabuoni2, Angelo Balestrazzi2, Chiara Fantozzi2, Chiara Lenzetti2, Marco Fantozzi2. 1. From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy. Electronic address: alexmalandrini@libero.it. 2. From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy.
Abstract
PURPOSE: To evaluate the biocompatibility of the Flexivue Microlens intracorneal inlay based on healing of corneal wounds and analysis of corneal structural features using in vivo confocal microscopy (IVCM) and anterior segment optical coherence tomography (AS-OCT). SETTING: Ophthalmology Department, Misericordia e Dolce Hospital, Prato, Italy. DESIGN: Case series. METHODS: The intracorneal inlay was inserted in a stromal pocket created in the nondominant eye of emmetropic presbyopic patients using a femtosecond laser. In vivo confocal microscopy and AS-OCT examinations were performed preoperatively and 1, 6, and 12 months postoperatively. RESULTS: The mean follow-up was 7.6 months. In the early postoperative period, IVCM showed intense cellular activity in the stroma around the inlay, edema, inflammation, and degenerative material deposition but normal regularity after 12 months. Anterior segment OCT showed a regular planar shape of the corneal pocket in all eyes. The mean of the side-cut angles was 30.7 degrees. The mean difference between the measured and planned pocket depth was 9.77 μm. At 1 month, hyperreflective areas beneath the inlay and microfolds were observed in 21 of the 52 eyes. After 12 months, the anterior segment profile was regular and interface pocket reflectivity decreased over time. Six patients had inlay removal postoperatively (3 before 6 months; 3 before 12 months); after removal, IVCM and AS-OCT showed clear corneas without signs of irregularity. CONCLUSION: In vivo confocal microscopy and AS-OCT analysis showed that the inlay elicited a low-level wound-healing response in its immediate vicinity with no alteration in the corneal structures. FINANCIAL DISCLOSURE: Dr. M. Fantozzi is a member of the Presbia medical advisory board. No other author has a financial or proprietary interest in any material or method mentioned.
PURPOSE: To evaluate the biocompatibility of the Flexivue Microlens intracorneal inlay based on healing of corneal wounds and analysis of corneal structural features using in vivo confocal microscopy (IVCM) and anterior segment optical coherence tomography (AS-OCT). SETTING: Ophthalmology Department, Misericordia e Dolce Hospital, Prato, Italy. DESIGN: Case series. METHODS: The intracorneal inlay was inserted in a stromal pocket created in the nondominant eye of emmetropic presbyopic patients using a femtosecond laser. In vivo confocal microscopy and AS-OCT examinations were performed preoperatively and 1, 6, and 12 months postoperatively. RESULTS: The mean follow-up was 7.6 months. In the early postoperative period, IVCM showed intense cellular activity in the stroma around the inlay, edema, inflammation, and degenerative material deposition but normal regularity after 12 months. Anterior segment OCT showed a regular planar shape of the corneal pocket in all eyes. The mean of the side-cut angles was 30.7 degrees. The mean difference between the measured and planned pocket depth was 9.77 μm. At 1 month, hyperreflective areas beneath the inlay and microfolds were observed in 21 of the 52 eyes. After 12 months, the anterior segment profile was regular and interface pocket reflectivity decreased over time. Six patients had inlay removal postoperatively (3 before 6 months; 3 before 12 months); after removal, IVCM and AS-OCT showed clear corneas without signs of irregularity. CONCLUSION: In vivo confocal microscopy and AS-OCT analysis showed that the inlay elicited a low-level wound-healing response in its immediate vicinity with no alteration in the corneal structures. FINANCIAL DISCLOSURE: Dr. M. Fantozzi is a member of the Presbia medical advisory board. No other author has a financial or proprietary interest in any material or method mentioned.