PMID- 32176161
OWN - NLM
STAT- MEDLINE
DCOM- 20210712
LR  - 20210712
IS  - 1873-4502 (Electronic)
IS  - 0886-3350 (Linking)
VI  - 46
IP  - 6
DP  - 2020 Jun
TI  - Safety and efficacy of custom foldable silicone artificial iris implantation: 
      prospective compassionate-use case series.
PG  - 893-901
LID - 10.1097/j.jcrs.0000000000000172 [doi]
AB  - PURPOSE: To assess the preliminary safety and efficacy of custom silicone 
      artificial iris implantation. SETTING: Stein Eye Institute. DESIGN: Prospective 
      consecutive case series. METHODS: Medical records of patients implanted with the 
      artificial iris were reviewed and followed for 1 year. Safety measures included 
      corrected distance visual acuity (CDVA), intraocular pressure (IOP), endothelial 
      cell count (ECC), surgical complications, secondary interventions, and adverse 
      events (AEs). Efficacy measures included CDVA with glare, subjective daytime and 
      nighttime glare graded from 0 to 10 (very significant), and subjective cosmetic 
      appearance graded from 0 to 10 (very satisfied). RESULTS: Twenty eyes (19 
      patients) were implanted. Safety data were mixed. CDVA improved in 13 eyes and 
      worsened in 6. ECC decreased from 1918 +/- 870 to 1405 +/- 705 cells/mm (P = .02). 
      Eight eyes experienced postoperative complications. There were 4 IOP elevations, 
      2 corneal decompensations, 1 case of cystoid macular edema, and 1 device 
      dislocation. Four eyes underwent secondary surgical interventions including 2 AEs 
      (1 glaucoma surgery and 1 device dislocation). Efficacy outcomes were excellent. 
      CDVA with glare improved from 1.5 +/- 0.6 to 0.7 +/- 0.8 logarithm of the minimum 
      angle of resolution (P < .01). Mean subjective daytime glare decreased from 8.9 +/- 
      1.8 to 2.7 +/- 2.6 (P < .01) and nighttime glare decreased from 7.9 +/- 1.8 to 2.5 +/- 
      2.7 (P < .01). Mean cosmesis improved from 2.2 +/- 1.6 to 8.8 +/- 2.1 (P < .01). 
      CONCLUSIONS: Custom artificial iris implantation was moderately risky but very 
      effective at reducing light and glare sensitivity and in improving ocular 
      cosmesis.
FAU - Bonnet, Clemence
AU  - Bonnet C
AD  - From the Department of Ophthalmology, Stein Eye Institute, David Geffen School of 
      Medicine at the University of California (Bonnet, Miller), Los Angeles, 
      California, USA; Opthalmole de Paris, Cochin Hospital, Paris Descartes University 
      (Bonnet), Paris, France.
FAU - Miller, Kevin M
AU  - Miller KM
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Cataract Refract Surg
JT  - Journal of cataract and refractive surgery
JID - 8604171
RN  - 0 (Silicones)
SB  - IM
MH  - Glare
MH  - Humans
MH  - *Iris/surgery
MH  - Postoperative Complications
MH  - Prospective Studies
MH  - *Silicones
MH  - Visual Acuity
EDAT- 2020/03/17 06:00
MHDA- 2021/07/13 06:00
CRDT- 2020/03/17 06:00
PHST- 2020/03/17 06:00 [pubmed]
PHST- 2021/07/13 06:00 [medline]
PHST- 2020/03/17 06:00 [entrez]
AID - 10.1097/j.jcrs.0000000000000172 [doi]
PST - ppublish
SO  - J Cataract Refract Surg. 2020 Jun;46(6):893-901. doi: 
      10.1097/j.jcrs.0000000000000172.