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Corneal stromal regeneration therapy for advanced keratoconus: clinical outcomes at 3 years

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First Author: M.El Zarif SPAIN

Co Author(s):    J. Alió                    

Abstract Details

Purpose:

This study evaluated the safety and efficacy results of 3 years outcomes of corneal stromal cell therapy. The therapy consisted of implanting within the cornea stroma of patients with advanced keratoconus, autologous adipose-derived adult stem cells (ADASc), with or without laminas of decellularized donated human corneal stroma.

Setting:

Division of Ophthalmology, Miguel Hernandez University, Alicante-Spain, Vissum Innovation, Alicante-Spain and Optica General, Saida-Lebanon.

Methods:

Fourteen consecutive patients were selected and divided into 3 experimental groups. Group-1 patients underwent implantation of autologous ADASc alone (3x106 cells/1 ml) (n = 5). Group-2 patients received decellularized donor corneal stroma lamina with 120 µm thick (n =5). Group-3, patients received implantation of recellularized donor lamina with (1x 106 cells/1 ml, half million in each side), and another (1x106 cells/1 ml) of ADASc injected during the surgery (n = 4). Autologous ADASc were obtained by elective liposuction. Implantation was performed into a femtosecond-assisted 9.5 mm diameter lamellar pocket, under topical anesthesia. 36 months of follow-up data are presented.

Results:

Three years postoperative, we obtained the following outcomes in G-1, G-2 & G-3 regarding the preoperative mean values: An increase of 1-2 logMar lines with the UVA, CDVA and CLVA. Rx Sphr showed an improvement of (1.1 D); Rx Cyl showed a change of (0.5 D) in all the groups. We obtained statistically significance in CCT with G-2 [P= 0.012] and G-3 [P< 0.001], Thinnest point in G-2 [P= 0.007] and G-3 [P= 0.001], aberrations of N=3 in G-2 [P < 0.001] and G-3 [P= 0.009] neither HOA in G-2 [P< 0.001] & G-3 [P= 0.038] comparing with the G-1.

Conclusions:

Implantation of autologous ADASc and decellularized human corneal stroma in the cornea stroma, did not show any complications after the 3 years follow-up and were moderately effective for the treatment of advanced keratoconus.

Financial Disclosure:

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