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From the FDA Summary of Safety and Effectiveness Data for the approval of the B&L Technolas 217A PDF Print E-mail
Monday, 14 November 2005 19:00

http://www.fda.gov/cdrh/pdf/p990027s004b.doc

e. Patient Symptoms

The occurrence rate for the symptoms dryness (22.6% vs. 10.5%, p<0.0001), gritty feeling (6.8% vs 2.6%), fluctuation of vision (14.7% vs. 5.7%, p-value = 0.0005), and variations of vision in dim light (18.1% vs. 27.9%, p<0.0032) were higher at the 6 month visit than at the preoperative visit.

Table 23

Patient Symptoms at Preop & 6 Months

All Treated Eyes

Patient Symptoms None Mild Moderate to Severe

% (n/N) % (n/N) % (n/N)

Preop. 6 Months Preop. 6 Months Preop. 6 Months

Light sensitivity 47.7% (167/350) 44.2% (121/274) 29.1% (102/350) 36.1% (99/274) 23.1% (81/350) 19.7% (54/274)

Headaches 68.6% (240/350) 84.7% (232/274) 19.7% (69/350) 12.4% (34/274) 11.7% (41/350) 2.9% (8/274)

Pain 89.4% (313/350) 92.0% (252/274) 8.3% (29/350) 6.9% (19/274) 2.3% (8/350) 1.1% (3/274)

Redness 75.4% (264/350) 71.9% (197/274) 18.6% (65/350) 20.4% (56/274) 6.0% (21/350) 7.7% (21/274)

Dryness 60.6% (212/350) 34.3% (94/274) 29.4% (103/350) 43.8% (120/274) 10.0% (35/350) 21.9% (60/274)

Tearing 76.3% (267/350) 88.3% (242/274) 16.3% (57/350) 9.1% (25/274) 7.4% (26/350) 2.6% (7/274)

Burning 77.1% (270/350) 77.0% (211/274) 19.4% (68/350) 20.8% (57/274) 3.4% (12/350) 2.2% (6/274)

Gritty feeling 77.4% (271/350) 67.9% (186/274) 19.7% (69/350) 25.5% (70/274) 2.9% (10/350) 6.6% (18/274)

Glare 59.1% (207/350) 49.6% (136/274) 28.9% (101/350) 37.6% (103/274) 12.0% (42/350) 12.8% (35/274)

Halos 82.0% (287/350) 73.7% (202/274) 11.1% (39/350) 16.4% (45/274) 6.9% (24/350) 9.9% (27/274)

Blurred vision 57.1% (200/350) 43.8% (120/274) 21.4% (75/350) 37.6% (103/274) 21.4% (75/350) 18.6% (51/274)

Double vision 91.7% (321/350) 82.5% (226/274) 5.1% (18/350) 12.0% (33/274) 3.1% (11/350) 5.5% (15/274)

Ghost images 92.3% (323/350) 78.8% (216/274) 4.9% (17/350) 16.8% (46/274) 2.9% (10/350) 4.4% (12/274)

Fluctuations of vision 70.0% (245/350) 38.3% (105/274) 24.3% (85/350) 47.1% (129/274) 5.7% (20/350) 14.6% (40/274)

Variation of vision in bright light 58.3% (204/350) 57.7% (158/274) 30.0% (105/350) 32.5% (89/274) 11.7% (41/350) 9.9% (27/274)

Variation of vision in normal light 78.9% (276/350) 63.5% (174/274) 16.0% (56/350) 29.2% (80/274) 5.1% (18/350) 7.3% (20/274)

Variation of vision in dim light 51.4% (180/350) 35.8% (98/274) 30.3% (106/350) 36.5% (100/274) 18.3% (64/350) 27.7% (76/274)

Night driving vision 43.4% (152/350) 59.5% (163/274) 38.0% (133/350) 29.6% (81/274) 18.6% (65/350) 10.9% (30/274)

N = Number of Self-evaluation Forms received with non-missing values at each visit.

At 6 months, the symptoms graded as moderate or worse that were reported at an incidence level of more than 1% higher than the baseline incidence level were redness, dryness, gritty feeling, halos, double vision, ghost images, fluctuations of vision, variation of vision in normal light, and variation of vision in dim light.