Document Detail

Risk factors for self-reported visual symptoms with Intacs inserts for myopia.
MedLine Citation:
PMID:  11772579     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Potential risk factors and visual performance measures were evaluated for relationship to self-report of clinical visual symptoms after the refractive procedure for placement of Intacs microthin prescription inserts for myopia.
DESIGN: Retrospective nonrandomized comparative study.
PARTICIPANTS/INTERVENTION: Patients were participants in the U.S. Food and Drug Administration phase III KeraVision prospective clinical trials.
MAIN OUTCOME MEASURES: Study participants (n = 263) were retrospectively classified into one of three outcome groups on the basis of postoperative self-reported visual symptoms and/or request for Intacs inserts removal through month 24. Differences between outcome groups in visual acuity, refractive error, corneal geometry, corneal topography, type of preoperative corrective lens wear, and demographic variables were evaluated with multivariate logistic regression.
RESULTS: Clinical trial participants who had preoperative mean keratometry >45 diopters (D) (adjusted odds ratio [OR], 0.43; 95% confidence interval [CI], 0.21, 0.85, P = 0.02), manifest refractive astigmatism of 0.75 D or 1.00 D (adjusted OR, 0.52; 95% CI, 0.25, 1.08, P = 0.08), measured uncorrected visual acuity > or =2 lines better than that predicted by their respective cycloplegic refractive error (adjusted OR, 0.39; 95% CI, 0.14, 1.12, P = 0.08) and/or had worn soft contact lenses (adjusted OR, 0.58; 95% CI, 0.32, 1.04, P = 0.07) tended to be less likely to report postoperative clinical visual symptoms with Intacs inserts. Risk of clinical visual symptoms and request for Intacs inserts removal approximately doubled for each 0.50 D of additional postoperative defocus equivalent (crude OR, 1.86; 95% CI, 1.39, 2.48, P = 0.00). Controlling for postoperative defocus and important preoperative risk factors, subjects who reported significant clinical visual symptoms were more likely to have had preoperative uncorrected visual acuity that was worse than that predicted by their respective cycloplegic refractive error (adjusted OR, 1.84; 95% CI, 0.98, 3.42, P = 0.06). Risk of reporting clinical visual symptoms was increased with mesopic pupil diameter > or =6.5 mm (adjusted OR, 1.76; 95% CI, 0.96, 3.24, P = 0.07). Within the group of patients who reported postoperative clinical visual symptoms, 71 of 122 (58%) had ceased reporting them by month 24.
CONCLUSIONS: Adjusting for important risk factors simultaneously, this study suggested that certain preoperative characteristics may increase or decrease the likelihood, depending on the characteristic, of refractive surgery candidates to report significant clinical visual symptoms with Intacs inserts.
Debby K Holmes-Higgin; Terry E Burris; Jodi A Lapidus; Merwyn R Greenlick
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Ophthalmology     Volume:  109     ISSN:  0161-6420     ISO Abbreviation:  Ophthalmology     Publication Date:  2002 Jan 
Date Detail:
Created Date:  2002-01-04     Completed Date:  2002-01-22     Revised Date:  2012-09-10    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  46-56     Citation Subset:  IM    
Northwest Corneal Services, Corneal Topography Research Center, 6950 SW Hampton, Suite 150, Portland, OR 97223, USA.
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MeSH Terms
Cohort Studies
Cornea / surgery*
Corneal Topography
Device Removal
Middle Aged
Myopia / surgery*
Polymethyl Methacrylate
Prospective Studies
Prostheses and Implants / adverse effects*
Prosthesis Implantation
Retrospective Studies
Risk Factors
Self Disclosure
Vision Disorders / diagnosis,  etiology*
Visual Acuity*
Reg. No./Substance:
9011-14-7/Polymethyl Methacrylate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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