Randomized clinical trial of a new dexamethasone delivery system (surodex) for treatment of post-cataract surgery inflammation

doi:10.1016/S0161-6420(99)90060-X

Ophthalmology

Volume 106, Issue 2, 1 February 1999, Pages 223-231

Presented at the 1997 American Society of Cataract and Refractive Surgery (ASCRS) Meeting, Boston, Massachusetts.

https://doi.org/10.1016/S0161-6420(99)90060-X Get rights and content

Abstract

Objective

To evaluate the safety of Surodex Drug Delivery System (Oculex Pharmaceuticals, Inc., Sunnyvale, CA) containing dexamethasone 60 μg, for use in cataract surgery, and to compare its anti-inflammatory efficacy with conventional dexamethasone 0.1% eyedrops.

Design

Randomized, masked, and partially controlled trial.

Participants

Sixty eyes of 60 Asian patients undergoing extracapsular cataract extraction with intraocular lens implantation were examined. Of these, 28 eyes of 28 patients served as control eyes. Patients were stratified for age and presence of diabetes mellitus.

Intervention

Surodex was inserted in the anterior chamber of 32 eyes at the conclusion of surgery. These eyes received placebo eyedrops four times a day after surgery for 4 weeks. Control eyes received neither Surodex nor a placebo implant but were prescribed conventional 0.1% dexamethasone eyedrops four times a day for 4 weeks.

Main outcome measures

Anterior chamber cells and flare were clinically graded at the slit lamp. Anterior chamber flare was objectively assessed with the Kowa FM500 Laser Flare Meter (Kowa Co. Ltd, Tokyo, Japan) for up to 3 months after surgery. Intraocular pressure and corneal endothelial specular microscopy with morphometric cell analysis were performed for up to 1 year after surgery.

Results

Clinical slit-lamp assessment of anterior chamber flare and cells showed no difference between Surodex-treated eyes and dexamethasone eyedrop-treated eyes. Flare meter readings showed lower flare levels in the Surodex group at all postoperative visits compared with the dexamethasone eyedrop group. Flare reduction in the Surodex group reached statistical significance at days 4, 8, 15, and 30 after surgery. At 3 months, flare was reduced to preoperative levels in the Surodex group but was still raised in the dexamethasone eyedrop group. Five eyes in the dexamethasone eyedrop group required augmentation of steroids and were deemed therapeutic failures as opposed to one eye in the Surodex group. One patient in the dexamethasone eyedrop group developed postoperative open-angle glaucoma with profound visual field loss and optic disc cupping, resulting in hand movements vision. No significant difference in endothelial cell loss was noted between Surodex-inserted eyes and dexamethasone eyedrop-treated eyes for up to 1 year after surgery.

Conclusions

Intraocular placement of a single Surodex is a safe and effective treatment method to reduce intraocular inflammation after cataract surgery. There was no statistical difference in efficacy between Surodex and 0.1% dexamethasone eyedrops in reducing intraocular inflammation, as measured by clinical methods, while Surodex was clearly superior to eyedrops in reducing aqueous flare as objectively assessed with the laser flare meter.

Section snippets

Patients and methods

Sixty patients undergoing elective extracapsular cataract extraction with intraocular lens implantation (ECCE/IOL) were enrolled in a prospective, double-masked, randomized, controlled clinical trial during the period from April 1996 to July 1997 at the Singapore National Eye Centre. The clinical trial protocol and informed consent form were approved by the Singapore National Eye Centre Ethics and Research Committees, and written informed consent was obtained. Inclusion criteria included

Results

Sixty eyes of 60 patients were enrolled in the study during April to June 1996, with 28 eyes in group A and 32 eyes in group B. The mean age of patients in groups and A and B was 67.1 years and 67.7 years, respectively, and the male-to-female ratio was 1:1.3. The majority of patients were Chinese (26 patients in group A, 29 patients in group B), with 3 Indian patients (1 in group A, 2 in group B) and 1 Malay patient in each group. This approximated the racial mix in Singapore, with a slight

Discussion

This study represents the first major human clinical trial utilizing the Surodex Drug Delivery System to deliver a controlled intraocular dosage of dexamethasone after cataract extraction. Surodex is superior to eyedrops in reducing aqueous flare in the first month after surgery, as measured by the laser flare meter. Eyes in the Surodex group achieved flare levels commensurate with near-complete resolution of inflammation earlier at 1 week, whereas similar levels in the steroid eyedrop groups

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^☆: Supported by Singapore National Medical Research Council (NMRC) Grant No: STB/0050/1991, and Oculex Pharmaceuticals, Inc., Sunnyvale, California. Also supported by research grants from the Totalisator Board of the Singapore National Medical Research Council and Oculex Pharmaceuticals, Inc.

¹: The authors have no financial interest in this or competing products or in Surodex or Oculex Pharmaceuticals, Inc.

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Randomized clinical trial of a new dexamethasone delivery system (surodex) for treatment of post-cataract surgery inflammation1☆,

Abstract

Objective

Design

Participants

Intervention

Main outcome measures

Results

Conclusions

Section snippets

Patients and methods

Results

Discussion

J Cataract Refract Surg

J Cataract Refract Surg

Am J Ophthalmol

J Cataract Refract Surg

J Cataract Refract Surg

Am J Ophthalmol

Vicryl® (Polyglactin 910)a new synthetic absorbable suture in ophthalmic surgery

Br J Ophthalmol

Pathophysiology and pharmacology of intraocular surgery

Aust N Z J Ophthalmol

New quantitative method to determine protein concentration and cell number in aqueous in vivo

Jpn J Ophthalmol

Diurnal variation of aqueous flare in normal human eyes measured with laser flare-cell meter

Jpn J Ophthalmol

Changes in aqueous flare and cells after mydriasis

Jpn J Ophthalmol

Randomized clinical trial of a new dexamethasone delivery system (surodex) for treatment of post-cataract surgery inflammation¹☆,