Results of phase III excimer laser photorefractive keratectomy for myopia. The Summit PRK Study Group.

OBJECTIVE

The purpose of the study is to determine safety and efficacy outcomes of excimer laser photorefractive keratectomy (PRK) for the treatment of mild-to-moderate myopia.

DESIGN

A prospective, multicenter, phase III clinical trial.

PARTICIPANTS

A total of 701 eyes of 701 patients were entered in the study; 612 eyes were examined at 2 years after surgery.

INTERVENTION

Intervention was photorefractive keratectomy using the Summit ExciMed UV200LA excimer laser (Summit Technology, Inc., Waltham, MA). The treatment zone diameter used was 4.5 mm in 251 eyes (35.8%) and 5 mm in 450 eyes (64.2%). Attempted corrections ranged from 1.50 to 6.00 diopters (D).

MAIN OUTCOME MEASURES

Predictability and stability of refraction, uncorrected and spectacle-corrected visual acuity, refractive and keratometric astigmatism, corneal haze, contrast sensitivity, subjective reported problems of glare and halo, and patient satisfaction were the parameters measured.

RESULTS

At 2 years, 407 (66.5%) eyes achieved 20/20 or better uncorrected visual acuity and 564 (92.5%) eyes achieved 20/40 or better visual acuity. Three hundred thirty-six (54.9%) eyes were within 0.5 D and 476 (77.8%) eyes were within 1.0 D of attempted correction. Stability of refraction improved with time; 86.8% of eyes were stable within 1.0 D from 6 to 12 months, 94% were stable from 12 to 18 months, and 96.3% were stable from 18 to 24 months. There was no evidence of progressive or late myopic or hyperopic refractive shifts. One hundred fourteen (18.6%) eyes gained 2 or more lines of spectacle-corrected visual acuity, whereas 42 (6.9%) eyes lost 2 or more lines; however, of the latter, 32 (76.2%) had spectacle-corrected visual acuity of 20/25 or better and 39 (92.9%) eyes had 20/40 or better. Four hundred forty-two (72.2%) corneas were clear, 138 (22.5%) showed trace haze, 20 (3.3%) mild haze, 9 (1.5%) moderate haze, and 3 (0.5%) marked haze. On patient questionnaires, 87 (29.7%) patients reported worsening of glare from preoperative baseline; 133 (50.1%) reported worsening of halo symptoms from baseline.

CONCLUSIONS

Photorefractive keratectomy appears effective for myopic corrections of -1.50 to -6.00 D. Uncorrected visual acuity is maximized in most eyes by 3 months, although some patients require between 6 months and 1 year to attain their best postoperative uncorrected visual acuity and some may require from 1 to 2 years for stabilization of refraction. Refraction stabilizes progressively without evidence of late myopic or hyperopic refractive shifts. Optical sequelae of glare and halo occur in some patients treated with a 4.5- or 5-mm treatment zone.