Study

Complication rate

Flap/interface complication

Management

Outcome

el Danasoury 2002

1 interface complication in 45 LASIK treatments. No other flap/decentered ablation complications

Diffuse lamellar keratitis 3 days after uneventful LASIK

Topical steroid therapy

Inflammation completely resolved within one week

Malecaze 2002

0 flap/interface/decentered ablation complications in 25 LASIK treatments

N/A

N/A

N/A

Schallhorn 2007

Flap/interface complications N/A as all treatments PRK. No decentered ablations or haze reported in 45 laser treatments

N/A

N/A

N/A

Study

Follow‐up

Findings

el Danasoury 2002

One year

The mean endothelial cell loss 0.7% ± 1.1% (range ‐3.1% to 1.7 %) at 1 year in the Artisan group and mean 0.3% ± 0.9% (range ‐1.9% to 1.8%) at 1 year in the LASIK group. There was no statistically significant difference between endothelial cell loss in the 2 groups

Malecaze 2002

One year

The differences between mean endothelial cell loss in LASIK treated eyes and Artisan‐treated eyes was not statistically different at either 3 months (P = 0.73) or 1 year (P = 0.60) postoperatively

Schallhorn 2007

Endothelial cell loss was not reported.

N/A

Study

IOL exchange rate

Indication for IOL exchange

Management

Outcome

el Danasoury 2002

1 eye (2.2%)

Severe night glare in a patient with a preoperative pupil at dim illumination of 5mm who received a 5 mm Artisan lens

Lens was removed and exchanged for a 6 mm Artisan lens

Night glare completely resolved. UCVA was 20/40 correcting to 20/20

Malecaze 2002

0 cases reported of IOL exchange

N/A

N/A

N/A

Schallhorn 2007

1 eye (2.3%)

Anterior subcapsular cataract resulting in BCVA 20/50^‐1

Phakic IOL and cataract were removed and replaced with pseudophakic IOL

BSCVA of 20/20

Study

Method

Findings

el Danasoury 2002

Measured using the Vision Contrast Test System (VCTS‐6000, Vistech consultants, Inc. Dayton, OH) performed under normal room lighting

One year after surgery the contrast sensitivity curve of each eye was compared to its baseline curve. Two Artisan eyes (4.7%) and six LASIK eyes (14.6%) lost 2 or more lines, three Artisan eyes (7.0%) and nine LASIK eyes (22.0%) lost 1 line, four Artisan eyes (9.3%) and no LASIK eyes gained 2 or more lines, and seven Artisan eyes (16.3%) and five LASIK eyes (12.2%) gained 1 line. The contrast sensitivity did not change in 27 Artisan eyes (62.8%) and 21 LASIK eyes (51.2%). There was no comment on whether this difference was statistically significant or not

Malecaze 2002

Not described

Pre‐operative contrast sensitivity measurements to one year postoperative measurements were slightly reduced in the LASIK group and slightly improved in the phakic IOL group. However this difference was not statistically significant at all 4 spatial frequencies (P = 0.66, 0.70, 0.06 and 0.29 for 3, 6, 12 and 18 cycles per degree cyc/deg respectively)

Schallhorn 2007

Photopic contrast sensitivity was conducted with a back‐illuminated chart (5% ETDRS Chart, 9x14, Model 2186; Precision Vision, LaSalle, ILL) with room lights off. Mesopic testing was conducted with a 25% ETDRS chart (Precision Vision) behind two neutral density filters and room lights off

5% photopic level: The mean BSCVA (logMAR) was significantly better in the phakic IOL group than the PRK laser group at all time points postoperatively (P = 0.002 at one week and P = <0.001 at all other time points). Loss of 2 or more lines of BSCVA was significantly higher in the PRK group at all time points except six months. Improvement in BSCVA by 2 or more lines and 1 or more lines was significantly better in the phakic IOL group from 1 to 12 months postoperatively

25% mesopic level: The mean BSCVA (logMAR) was significantly better in the phakic IOL group than the PRK laser group at all time points postoperatively (P = 0.048 at one week and P = <0.001 at all other time points). Improvement in BSCVA (2 or more lines) was significantly better in the phakic IOL group at all time points from 1 to 12 months. Losses of 1 or more lines of BSCVA was significantly higher in the PRK group at all time points after one week. Improvement of one or more lines of BSCVA was better in the phakic IOL series at 1, 3 and 12 months

Study

Methods

FIndings

el Danasoury 2002

Patient satisfaction and preference questionnaire at 12 months postoperatively. This was only given to the 18 patients that had Artisan in one eye and LASIK in the other eye

There was no significant difference in the satisfaction levels between the two groups. 11 patients (61.1%) experienced more night glare or halos with their LASIK eye, 3 patients (16.7%) had more night glare with their Artisan eye, 1 patient (5.6%) reported equal glare in both eyes and 3 patients (16.7%) said that they had no glare with either eye (P = 0.001)

Patient preference for Artisan was significantly higher (P = 0.0001) mainly because of better reported quality of vision

Malecaze 2002

Patient satisfaction questionnaire at 12 months postoperatively

There was a slightly significantly increased frequency of halos following LASIK (P = 0.05) and non‐significantly increased frequency of halos following Artisan (P = 0.19). Both groups showed a significantly increased frequency of glare (P = 0.02 for LASIK and P = 0.01 for Artisan) but there was no statistically significant difference between the two groups (P = 0.30 for halos and P = 0.20 for glare). The satisfaction levels were not statistically different (P = 0.40) between the two groups. Concerning preference for one of the two techniques: 16% of patients preferred LASIK, 44% preferred Artisan and 40% had no preference

Schallhorn 2007

Psychometric questionnaire was given preoperatively and 3, 6 and 12 months postoperatively. The questionnaire assessed subjective quality of vision (glare, halos, night vision, need for artificial tears) and satisfaction after the surgery

The PRK group showed significantly more need for artificial tears (P = 0.002) and more visual fluctuation (0.001) at the 3 and 6 month postoperative time periods. The PRK group had more glare symptoms at night (P = 0.033) and more trouble with oncoming car headlights at night (P = 0.014). All other questions at 3 and 6 months showed no difference between the two groups. The 12‐month questionnaire showed similar subjective visual results between the two groups with the exception of greater use of artificial tears in the PRK group (P = 0.008) and greater glare when watching television or computer monitors (P = 0.043)