Implantable contact lens for moderate to high myopia: Phase 1 FDA clinical study with 6 month follow-up
| Autor: | John R. Shepherd, Maryclare DeLuca, Donald R. Sanders, Robert G. Martin, David C. Brown, Michael R. Deitz |
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| Rok vydání: | 1998 |
| Předmět: |
Adult
Male Refractive error medicine.medical_specialty Visual acuity genetic structures Contact Lenses Eye disease Visual Acuity Emmetropia Prosthesis Implantation Vision disorder Ophthalmology Myopia Humans Medicine Dioptre business.industry medicine.disease eye diseases Sensory Systems Surgery Contact lens Implantable Contact Lens Female Safety medicine.symptom business Follow-Up Studies |
| Zdroj: | Journal of Cataract and Refractive Surgery. 24:607-611 |
| ISSN: | 0886-3350 |
| DOI: | 10.1016/s0886-3350(98)80254-x |
| Popis: | Purpose: To assess the short-term safety and efficacy of the implantable contact lens (ICL™) to treat, moderate to high myopia, Setting: Phase 1 U.S. Food and Drug Administration clinical study of the ICL conducted at four sites in the United States. Methods: Ten patients with myopia of 7,00 diopters (D) or greater had implantation of a Staar Surgical ICL and were examined preoperatively (baseline) and 1 day, 1 week, and 1, 3, and 6 months postoperatively. Mean preoperative myopia was 7.75 D (range 7.25 to 9.37 D): Results: Six months postoperatively, 5 of 10 eyes (50%) had an uncorrected visual acuity (UCVA) of 20/20 or better, and all eyes had a UCVA of 20/30 or better. All eyes had a best spectacle-corrected visual acuity (BSCVA), of 20/20 or better and 6 eyes (60%), of 20/15 or better. Six eyes (60%) had an improvement of one or more lines of BSCVA. Mean postoperative spherical equivalent was −0.025 D ± 0.47 (SD). Eight eyes (80%) were within ±0.250 D of emmetropia, and all were within ±1.125 D. No intraoperative or postoperative complications or adverse reactions were observed. Conclusions: The results support the short-term safety, efficacy; and predictability of ICL implantation to treat moderate to high myopia. |
| Databáze: | OpenAIRE |
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