Table 1.
Number of Adverse Events by Treatment Group in the Infant Aphakia Treatment Study
| Adverse Event | Treatment | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CL (57 Patients) | IOL (57 Patients) | |||||||||||
| During First Post-op Year | After First Post-op Year | Total | During First Post-op Year | After First Post-op Year | Total | |||||||
| # Ev | # Pat | # Ev | # Pat | # Ev | # Pat (%) | # Ev | # Pat | # Ev | # Pat | # Ev | # Pat (%) | |
| Lens Reproliferation into Visual Axis | 1 | 1 | 1 | 1 | 2 | 2 (4%) | 27 | 23 | 1 | 1 | 28 | 23* (40%) |
| Pupillary Membrane | 0 | 0 | 2 | 2 | 2 | 2 (4%) | 20 | 16 | 5 | 3 | 25 | 16† (28%) |
| Corectopia | 1 | 1 | 0 | 0 | 1 | 1 (2%) | 15 | 13 | 4 | 4 | 19 | 16‡ (28%) |
| Glaucoma | 3 | 3 | 6 | 6 | 9 | 9 (16%) | 7 | 7 | 4 | 4 | 11 | 11 (19%) |
| Glaucoma Suspect | 2 | 2 | 10 | 10 | 11 | 11§ (19%) | 3 | 3 | 3 | 3 | 5 | 5§ (9%) |
| CL Related AEs ^ | 4 | 3 | 14 | 7 | 18 | 10 (18%) | 0 | 0 | 0 | 0 | 0 | 0 (0%) |
| Vitreous Hemorrhage | 2 | 2 | 0 | 0 | 2 | 2 (4%) | 4 | 4 | 1 | 1 | 5 | 5 (9%) |
| Retinal Hemorrhage | 2 | 2 | 0 | 0 | 2 | 2 (4%) | 3 | 3 | 0 | 0 | 3 | 3 (5%) |
| Hyphema | 1 | 1 | 0 | 0 | 1 | 1 (2%) | 3 | 3 | 2 | 1 | 5 | 4 (7%) |
| Retained Cortex | 2 | 2 | 0 | 0 | 2 | 2 (4%) | 4 | 3 | 0 | 0 | 4 | 3 (5%) |
| Retinal Detachment | 2 | 2 | 0 | 0 | 2 | 2 (4%) | 0 | 0 | 0 | 0 | 0 | 0 (0%) |
| Endophthalmitis | 1 | 1 | 0 | 0 | 1 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 (0%) |
| Phthisis Bulbi | 1 | 1 | 0 | 0 | 1 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 0 (0%) |
| Corneal Edema >30 days | 0 | 0 | 0 | 0 | 0 | 0 (0%) | 1 | 1 | 0 | 0 | 1 | 1 (2%) |
| Wound Leak/Dehiscence | 0 | 0 | 0 | 0 | 0 | 0 (0%) | 1 | 1 | 0 | 0 | 1 | 1 (2%) |
| IOL Capture | 0 | 0 | 0 | 0 | 0 | 0 (0%) | 0 | 0 | 1 | 1 | 1 | 1 (2%) |
| Total× | 22 | 15 | 33 | 24 | 54§ | 32|| (56%) | 88 | 44 | 21 | 14 | 108§ | 46¶ (81%) |
Ev = Number of adverse events; # Pat = Number of patients, CL = Contact Lens group, IOL = IOL group, AE = Adverse Event
1 patient had lens reproliferation into the visual axis in both time periods.
3 patients had pupillary membrane in both time periods.
1 patient had corectopia in both time periods.
1 patient in the CL group and 1 patient in the IOL group changed from glaucoma suspect in the first time period to glaucoma in the second time period.
7 patients in the CL group had at least 1 adverse event in both time periods.
12 patients in the IOL group had at least 1 adverse event in both time periods.
For number of patients the total refers to the number of patients with at least 1 adverse event.
Contact lens related AE’s included corneal abrasions, corneal ulcers and episodes of keratitis