A prospective multicenter trial of excimer laser phototherapeutic keratectomy for corneal vision loss. The Summit Phototherapeutic Keratectomy Study Group

The 193-nm argon fluoride excimer laser can remove corneal scars and smooth corneal irregularities, obviating corneal transplantation. We conducted a prospective multicenter trial of excimer laser phototherapeutic keratectomy for corneal vision loss as a basis for Food and Drug Administration premar...

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Bibliographic Details
Published in:American journal of ophthalmology 1996-08, Vol.122 (2), p.149-160
Main Authors: Maloney, R K, Thompson, V, Ghiselli, G, Durrie, D, Waring, 3rd, G O, O'Connell, M
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Cornea - surgery
Corneal Opacity - complications
Corneal Opacity - surgery
Female
Follow-Up Studies
Humans
Lasers, Excimer
Male
Middle Aged
Photorefractive Keratectomy
Postoperative Complications
Prospective Studies
Refraction, Ocular
Vision Disorders - etiology
Vision Disorders - surgery
Visual Acuity
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Summary:The 193-nm argon fluoride excimer laser can remove corneal scars and smooth corneal irregularities, obviating corneal transplantation. We conducted a prospective multicenter trial of excimer laser phototherapeutic keratectomy for corneal vision loss as a basis for Food and Drug Administration premarket approval. We treated 232 eyes of 211 patients with corneal vision loss. All had corneal pathology in the anterior 100 microns of the stroma. Mean postoperative follow-up was 10 +/- 8 months. The primary outcome variable was change in best spectacle-corrected visual acuity. At postoperative month 12, best spectacle-corrected visual acuity improved in 46 (45%) of 103 eyes and worsened in nine (9%) of 103 eyes by 2 or more Snellen lines. Best spectacle-corrected visual acuity improved by a mean of 1.6 +/- 2.8 Snellen lines (95% confidence interval, 1.1 to 2.1 lines). Every postoperative visit confirmed statistically significant improvement of mean best spectacle-corrected acuity. At month 12, treated eyes had a mean hyperopic shift in refraction of 0.87 diopter and a mean reduction in astigmatism of 0.36 diopter. Treatment appeared most effective in eyes with hereditary corneal dystrophies, Salzmann's nodular degeneration, and corneal scars, and least effective in eyes with calcific band keratopathy. Complications included recurrence of underlying pathology, corneal graft rejection, and bacterial keratitis. Argon fluoride excimer laser phototherapeutic keratectomy is effective, with relatively few complications, for treating vision loss from corneal opacification or irregularity. Efficacy, however, varies widely depending upon individual eyes and underlying diagnoses.
ISSN:0002-9394