Abstract
Purpose. In vitro and in vivo safety and efficacy evaluation of a CDRi made of poly(D,L-lactide-co-glycolide) 50/50 and a 5-FU antimitotic. Methods. The flexible "C" shaped CDRi device (0.7mm cross-section, 21mm long) contains 2mg of 5-FU and was calculated to release 4.5p,g 5-FU/hr to maintain a = 10[j.g 5-FU/ml concentration in the capsular bag-anterior chamber space, well above therapeutic threshold (= 0.2[4.g/ml) and below toxic level (60|0.rn/ml). In vitro characteristics were assessed in an artificial eye at 36°C with an aqueous flow of 20M-l/min. (10 times normal). The device is inserted in the empty capsular bag using a 19ga instrument. 3 control groups: 6 rabbits without capsule polishing, 6 with capsule polishing, 6 with capsule polishing and a CDRi without 5-FU. A fourth group of 6 receives a 5-FU CDRi. Follow-up stops 1 week after the onset of secondary cataract and histology is performed. Result?. The CDRi released 5-FU for = 50 days m vitro. In vivo, the onset of secondary cataract in controls was =3 weeks. Implant biodégradation takes =100days. The pharmacological, clinical, and histological results of this ongoing study will be presented. Conclusion. The intraocular 5-FU concentrations and long term effect on comeal endothelium have to be further assessed. The 5-FU CDRi needs refinement for insertion though a 3mm corneal incision and is promising.
| Original language | English |
|---|---|
| Journal | Investigative Ophthalmology and Visual Science |
| Volume | 38 |
| Issue number | 4 |
| State | Published - Dec 1 1997 |
Fingerprint
ASJC Scopus subject areas
- Ophthalmology
Cite this
Intracapsular controlled drug release implant (CDRi) designed to prevent secondary cataract. / Fragoso, M.; Tahi, H.; Gautier, S. E.; Duchesne, B.; Lallet, Z. V.; Hernandez, E.; Villain, F.; Parrish, Richard K; Parel, Jean-Marie A.
In: Investigative Ophthalmology and Visual Science, Vol. 38, No. 4, 01.12.1997.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Intracapsular controlled drug release implant (CDRi) designed to prevent secondary cataract
AU - Fragoso, M.
AU - Tahi, H.
AU - Gautier, S. E.
AU - Duchesne, B.
AU - Lallet, Z. V.
AU - Hernandez, E.
AU - Villain, F.
AU - Parrish, Richard K
AU - Parel, Jean-Marie A
PY - 1997/12/1
Y1 - 1997/12/1
N2 - Purpose. In vitro and in vivo safety and efficacy evaluation of a CDRi made of poly(D,L-lactide-co-glycolide) 50/50 and a 5-FU antimitotic. Methods. The flexible "C" shaped CDRi device (0.7mm cross-section, 21mm long) contains 2mg of 5-FU and was calculated to release 4.5p,g 5-FU/hr to maintain a = 10[j.g 5-FU/ml concentration in the capsular bag-anterior chamber space, well above therapeutic threshold (= 0.2[4.g/ml) and below toxic level (60|0.rn/ml). In vitro characteristics were assessed in an artificial eye at 36°C with an aqueous flow of 20M-l/min. (10 times normal). The device is inserted in the empty capsular bag using a 19ga instrument. 3 control groups: 6 rabbits without capsule polishing, 6 with capsule polishing, 6 with capsule polishing and a CDRi without 5-FU. A fourth group of 6 receives a 5-FU CDRi. Follow-up stops 1 week after the onset of secondary cataract and histology is performed. Result?. The CDRi released 5-FU for = 50 days m vitro. In vivo, the onset of secondary cataract in controls was =3 weeks. Implant biodégradation takes =100days. The pharmacological, clinical, and histological results of this ongoing study will be presented. Conclusion. The intraocular 5-FU concentrations and long term effect on comeal endothelium have to be further assessed. The 5-FU CDRi needs refinement for insertion though a 3mm corneal incision and is promising.
AB - Purpose. In vitro and in vivo safety and efficacy evaluation of a CDRi made of poly(D,L-lactide-co-glycolide) 50/50 and a 5-FU antimitotic. Methods. The flexible "C" shaped CDRi device (0.7mm cross-section, 21mm long) contains 2mg of 5-FU and was calculated to release 4.5p,g 5-FU/hr to maintain a = 10[j.g 5-FU/ml concentration in the capsular bag-anterior chamber space, well above therapeutic threshold (= 0.2[4.g/ml) and below toxic level (60|0.rn/ml). In vitro characteristics were assessed in an artificial eye at 36°C with an aqueous flow of 20M-l/min. (10 times normal). The device is inserted in the empty capsular bag using a 19ga instrument. 3 control groups: 6 rabbits without capsule polishing, 6 with capsule polishing, 6 with capsule polishing and a CDRi without 5-FU. A fourth group of 6 receives a 5-FU CDRi. Follow-up stops 1 week after the onset of secondary cataract and histology is performed. Result?. The CDRi released 5-FU for = 50 days m vitro. In vivo, the onset of secondary cataract in controls was =3 weeks. Implant biodégradation takes =100days. The pharmacological, clinical, and histological results of this ongoing study will be presented. Conclusion. The intraocular 5-FU concentrations and long term effect on comeal endothelium have to be further assessed. The 5-FU CDRi needs refinement for insertion though a 3mm corneal incision and is promising.
UR - http://www.scopus.com/inward/record.url?scp=33749095492&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33749095492&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:33749095492
VL - 38
JO - Investigative Ophthalmology and Visual Science
JF - Investigative Ophthalmology and Visual Science
SN - 0146-0404
IS - 4
ER -