Removal of INTACS for myopia.
OBJECTIVE
To evaluate the safety and efficacy of the removal of INTACS.


METHODS
Subgroup analysis from a nonrandomized comparative interventional trial.


METHODS
Four hundred fifty-two patients with best spectacle-corrected visual acuity of 20/20 or better and myopia (1.0-3.5 diopters [D]) were enrolled in the U.S. Food and Drug Administration clinical trials of INTACS. Forty-six eyes among a total of 684 underwent INTACS removal.


METHODS
INTACS removal.


METHODS
Safety and efficacy of INTACS removal was assessed by comparison of results from preoperative and 3-month postremoval visits. Safety was assessed by maintenance of preoperative best spectacle-corrected acuity and induction of astigmatism (measured by manifest refraction). Efficacy was assessed by comparison of mean spherical equivalent measured by both manifest and cycloplegic refraction, as well as percentage of eyes within +/- 0.5 D and +/- 1.0 D of baseline values. A subset of 27 patients completed a prospective questionnaire assessing the frequency of six visual symptoms (glare, halos, double vision, photophobia, night vision difficulties, and fluctuating vision).


METHODS
Best spectacle-corrected visual acuity, manifest refraction, and cycloplegic refraction.


RESULTS
Forty-one of 46 patients' eyes that had undergone INTACS removal had reached the 3-month postremoval visit. Of these eyes, 73% (30 of 41) had returned to within +/- 0.5 D and 97% (40 of 41) to within +/- 1.0 D of baseline spherical equivalent as measured by manifest refraction. With respect to astigmatism, 88% (36 of 41) had returned to within +/- 0.5 D and 100% (41 of 41) to within +/- 1.0 D of preoperative value. No patient had a loss of best spectacle-corrected acuity of more than 2 lines, with equal numbers of eyes having a loss or gain of 1 line (nine eyes) and 2 lines (one eye). For most eyes, INTACS removal was associated with a substantial reduction in the six types of visual symptoms; however, in some eyes (up to 15%) symptoms that had not been detected preoperatively were noted after INTACS removal.


CONCLUSIONS
INTACS removal was not associated with a loss (> 2 lines) of best spectacle-corrected visual acuity or induction (> 1 D) of astigmatism or myopia. INTACS removal was associated with a reversal to preoperative values in most cases.
Clinch
Thomas E
TE
University Ophthalmic Consultants of Washington, DC 20016, USA.
Lemp
Michael A
MA
Foulks
Gary N
GN
Schanzlin
David J
DJ
D000328:Adult; D000368:Aged; D003315:Cornea / Q000503:physiopathology / Q000601:surgery*; D020878:Device Removal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D019904:Polymethyl Methacrylate; D011183:Postoperative Complications / Q000503:physiopathology / Q000601:surgery; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D012029:Refraction, Ocular; D012030:Refractive Errors / Q000503:physiopathology; D054140:Refractive Surgical Procedures; D012449:Safety; D014792:Visual Acuity
D019904:Polymethyl Methacrylate