Trans-Scleral Plugs Fixated Carlevale Iol : A Review Of Literature And Comparison With Other Techniques.

The purpose of this study is to revise systematically published results of the Carlevale IOL trans-scleral plug implant and to compare them with other published techniques.

Humanitas University, Pieve Emanuele, Milan, Italy

The peer-reviewed literature was analyzed and all relevant articles were selected. A literature search was conducted in April 2021 in Medline, the Cochrane Library, databases of clinical trials and was limited to studies published in English. The search strategy used the following MeSH terms and text words: sutureless scleral fixation, Carlevale, sutureless scleral lens, Carlevale IOL. The initial search yielded 36 citations. The authors reviewed 25 abstracts and selected 6 articles of possible clinical relevance to review in full text. Of these, 4 were considered to be sufficiently clinically relevant.

Cystoid macular edema was reported between 3.1% and 7.4%, IOP increase was reported between 3.1% and and 16.5%, vitreous hemorrage between 3.1% and  4.7%, retinal detachment was reported between 1.8% and 2.5%We performed a one-way ANOVA for the complications more extensively reported across the different implants:cystoid macular edema, vitreous hemorrhage and retinal detachment. No significant statistical difference was found in the rates of CME (p=0.20) and vitreous hemorrhage (p=0.89) while there was a statistically significant difference in the rates of retinal detachment (p=0.04).

In conclusion, published studies show that the Carlevale IOL is a safe device with outcomes not inferior to other techniques and an encouraging low complication rate. Prospective studies are needed to strengthen the scientific evidence of this technique usefulness.