Epikeratophakia: the surgical correction of aphakia. III. Preliminary results of a prospective clinical trial.

Epikeratophakia is a newly developed, investigational form of refractive corneal surgery for the correction of aphakic vision. The procedure involves the removal of the corneal epithelium from the recipient eye and the suturing of a prelathed lamellar donor corneal graft onto the surface of the recipient cornea. We initiated a prospective clinical trial of epikeratophakia in comparison with keratomileusis; however, only 14 patients were randomized between the two procedures, after which the protocol was modified to eliminate the keratomileusis procedure. subsequently, all patients who entered into the study underwent epikeratophakia. The limited comparative study showed that epikeratophakia was at least as effective as keratomileusis in terms of visual potential and visual recovery. The major problem encountered was undercorrection, which was largely eliminated by the use of donor tissue larger in diamter than the recipient bed. Three months postoperatively, five of seven patients undergoing epikeratophakia had 20/50 or better visual acuity with spectacle overcorrection.

RCT Entities:   Population Interventions Outcomes