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LUMENIS SELECTA - Posterior Capsulotomy Risks and Precautions

LUMENIS SELECTA
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Selecta
PBL200051, Rev J
106 Professional Use Instructions
status should be evaluated prior to, and monitored closely during and after,
procedures in which high pulse energies are used. In addition, the transient
rise in IOP that follows Nd:YAG laser posterior capsulotomy in many patients
should also be monitored following pupillary membranectomy. The release of
debris due to disruption of pupillary membranes should be recognized for
potential impact on IOP.
Poor candidates for posterior capsulotomy
Patients with any of the following conditions may not be suitable candidates
for posterior capsulotomy or pupillary membranectomy because the
procedure may not improve visual acuity or visualization of the posterior
segment, or may pose a special risk to the patients eyesight:
active ocular disease
nystagmus, blepharospasm, or other neurological conditions that
make ocular fixation impossible
slight or moderate haze of the aqueous humor or cornea
inability to cooperate in positioning and immobilization
poor vision (20/40 or worse) and clear optical media including the
capsule
20/30 or better preoperative vision and no other serious vision
disability, such as glare or poor reading vision, associated with the
posterior capsule condition. (Several clinical studies have shown
that 2-7% of these subjects experience a decrease in postoperative
vision.)
Intraocular pressure rise
Significantly increased IOP has been reported in a substantial number of laser-
treated patients, particularly those presenting with preoperative glaucoma or
preoperative IOP of greater than 20 mm Hg, and those with other evidence of
deranged aqueous dynamics or poor outflow facility. Other risk factors for
elevations of IOP include:
use of high amounts of energy during the procedure,
absence of an IOL, and
use of cycloplegic drugs
Physicians should carefully monitor all subjects for IOP rise in the 2-5 hours
after treatment with the laser. Patients who exhibit a pressure rise generally
return to pretreatment levels within 24 hours but should be carefully followed
throughout this period. Persistent IOP elevation occurs in some patients.
Clinical estimates are that 2-3% of patients may be treated for secondary
glaucoma.

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