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Epikeratophakia is a simple and reversible form of refractive surgery for the correction of aphakia and myopia and for the treatment of keratoconus, perforation and pterygium. The tissue lenses are attached to the de-epithelialised cornea; no invasion of the central optical zone is required. The safety of this procedure makes it a potential solution to the problem of optical correction in infants and children with congenital and traumatic cataracts. With the advent of commercially prepared tissue lenses, this surgery should become accessible to many ophthalmic surgeons. In the future, the combination of epikeratophakia and alloplastic lenses may provide high plus powers and exchangeable dioptric corrections, if a plastic can be found that the cornea will tolerate on a long-term basis.

In the nationwide study of epikeratophakia, 154 ophthalmic surgeons who had attended a training course performed 519 procedures for the correction of aphakia in adults: 310 of the eyes had 30 or more days of follow-up after suture removal. Of 229 eyes, 172 (75%) were within 3 diopters of emmetropia after surgery. Of 259 eyes, 245 (95%) demonstrated improved uncorrected visual acuity; 138 (53%) improved by four or more Snellen lines. Of 265 eyes, 209 (78%) achieved within two lines or improved their best corrected visual acuity. Of the 119 patients who achieved or improved their preoperative best corrected visual acuity, 110 (92%) were within two Snellen lines or better by 30 to 60 days after suture removal. Of the 127 patients with more than three months of follow-up after suture removal, 124 (98%) of those between 18 and 70 years of age but only 13 of 23 (54%) of those between 81 and 87 years of age achieved within two lines or better of their best corrected visual acuity. Corneal astigmatism measured by keratometry changed from a preoperative mean (+/- S.D.) of 2.1 +/- 1.8 diopters to a postoperative mean of 2.7 +/- 2.6 diopters. Of the 519 tissue lenses, 22 (4%) were removed, and one third of these patients underwent a second, successful epikeratophakia procedure.

The results of a prospective clinical study of hyperopic epikeratophakia grafts for the visual rehabilitation of aphakic patients are presented. Visual acuity data are given for 21 aphakic patients who have been followed for up to six months postoperatively. With spectacle overrefraction, on the average, patients were within three lines of their preoperative potential vision at three months postoperative and within two lines at six months postoperative. Three months postoperatively, two patients achieved visual acuities of 20/20, and 57% had 20/40 or better with spectacle overcorrection. Six months postoperatively, three patients achieved best-corrected visual acuities of 20/20, and 80% had best-corrected visual acuities of 20/40 or better.

Corneal sensitivity was tested in 60 eyes of 30 patients who underwent unilateral epikeratophakia for the correction of aphakia (20 patients) or keratoconus (10 patients). Postoperative recovery time ranged from 2 months to 21 months (mean: 10 months). Our results indicate a relative hypesthesia of the epikeratophakia lenticule when compared with the peripheral host cornea and contralateral control cornea. However, corneal sensitivity tested in 11 patients with more than 1 year follow-up was increased compared with the sensitivity of 19 patients whose postoperative recovery was less than 1 year. Histopathologic findings in two lenticules from a nonhuman primate demonstrated sparse epithelial axon terminals. Host corneal nerves appear to innervate the lenticules by intraepithelial extension and by penetration of the superficial keratectomy scar.

The records of all adult patients at Louisiana State University Eye Center, New Orleans, who underwent epikeratophakia for aphakia with commercially prepared tissue since February 1984 were reviewed. The epikeratophakia lenticule was maintained in 37 (92.5%) of 40 patients; complications required the removal of three tissue lenses. The average refractive error three months after surgery was +0.67 +/- 1.97 diopters; 25 (90%) of 28 patients were within 3 D of emmetropia. At six months, the average refractive error was -0.18 +/- 2.27 D. Fourteen (58%) of 24 patients whose visual acuity was 20/40 or better with spectacles before surgery achieved 20/40 spectacle visual acuity three months after surgery, as did ten (59%) of 17 patients at six months and five (83%) of six patients at 12 months. The results in these recent cases are better than in previously reported series and reaffirm the usefulness of epikeratophakia in the treatment of aphakia.

In the nationwide study of epikeratophakia, 97 surgeons performed a total of 335 procedures in 314 eyes for the correction of aphakia in children under the age of 8 years 1 month. Fifteen children underwent bilateral surgery. Thirty-six tissue lenses were removed and 21 of these eyes underwent a second epikeratophakia procedure. Overall, the success rate for procedures was 89%, and with repeated surgery it was 95% for eyes. Seventy-three percent of the patients were within 3 diopters of emmetropia after surgery. Visual acuity results in patients able to provide verbal responses to the illiterate E, Allen card, or Snellen line chart testing showed improvement in most cases. The safety of epikeratophakia makes it a desirable option for the correction of aphakia in children who are spectacle or contact-lens intolerant, and the permanence of the correction eliminates the problem of optical noncompliance.

A nationwide study of epikeratophakia for aphakia in older children was conducted from March 1984 to March 1986. Sixty-three patients, 8 to 18 years of age, underwent this procedure in 65 eyes. Twenty-eight patients had congenital cataracts and 35 had traumatic cataracts. Fifty-one of the 65 eyes were aphakic at the time of surgery (secondary procedures). All surgeries were successful; no tissue lenses were lost or removed. Postoperatively, 73% of the patients were within 3 diopters (D) of emmetropia. The patients with congenital cataracts gained an average of one Snellen line of best-corrected visual acuity; patients with traumatic cataracts lost an average of one Snellen line of best-corrected visual acuity. In older pediatric patients, epikeratophakia appears to be a safe and effective procedure for the correction of aphakia.