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Ophthalmic Devices Panel Advisory Committee Meeting Brief Summary for March 5, 2004

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BRANCH UPDATES

VITREORETINAL AND EXTRAOCULAR DEVICES BRANCH (VEDB)
Presented by:
Karen Warburton, M.S., Microbiologist


One of the device types that VEDB reviews is the ophthalmic sponge, which is used during LASIK surgery. We have recently become aware of MDR (Medical Device Reports) that identified an association between ophthalmic sponges and diffuse lamellar keratitis. Testing of a sample of ophthalmic sponges from a lot associated with a cluster of diffuse lamellar keratitis (DLK) cases showed significantly higher levels of bacterial endotoxin than a different lot. Additional MDRs have reported an association between microkeratomes and DLK.

Endotoxin has been shown to cause DLK in a rabbit model and there have been reports in the literature implicating endotoxin from sterilizer water reservoirs as a cause of DLK outbreaks. Additionally, a variety of other etiological factors have been suggested. However, endotoxin-contaminated ophthalmic sponges have not previously been identified as a possible cause. Endotoxin contaminated water used during device manufacture is a potential source. Historically, FDA has not required that ophthalmic sponges or other devices used in LASIK surgery be pyrogen (i.e. endotoxin) free and they are typically not labeled as such (although many may in fact be endotoxin free.)

Our Branch is working with other Center offices to make the ophthalmic community aware of this potential cause of DLK through letters to professional organizations and letters to the editor in journals which we anticipate will be published in the near future. We hope to encourage reporting of DLK to FDA and to stimulate both user and FDA investigation of DLK outbreaks so that we can better understand the role that ophthalmic devices and endotoxin play and make changes in our product review policies if warranted.

PANEL DELIBERATIONS

Clear Lens Extraction for the Correction of Presbyopia

Clear Lens Extraction (CLE) is an intraocular surgical procedure in which the non-cataractous crystalline lens is removed and replaced with a multifocal or accommodative lens for refractive correction. The panel discussed issues related to the appropriate clinical trial design for the evaluation of a multifocal intraocular lens (MIOL) or accommodative IOL (AIOL) in a cohort of subjects who have undergone CLE to correct presbyopia.

CLE and implantation of an MIOL or AIOL has been performed as an “off label” practice for several years, mainly in eyes with high refractive errors. There are currently no Standards or Guidance available for CLE with an intraocular lens, nor ar there any Standards or Guidance for devices solely intended for the correction of presbyopia.

After a presentation of the issues by Drs. Malvina Eydelman and Joseph Blustein of FDA, the panel was asked to discuss questions specific to the issue. There was no vote taken nor consensus requested of the panel. The purpose of the deliberations was to assist the Agency in working with industry to design clinical trial protocols that would establish the reasonable safety and effectiveness of CLE with implantation of an MIOL or AIOL.

A majority of the panel recommended

  1. The study should include historical controls to measure safety and active controls to measure effectiveness.
  2. A clinical study of patients with myopia should include those with myopia up to 10 diopters (D).
  3. The minimum age of 40-45 years was suggested.
  4. A minimum preoperative endothelial cell count should be calculated to determine suitability for inclusion in the study.
  5. The primary safety endpoint should be the incidence of retinal detachment with an acceptable rate of 0.3% for all patients except those with high myopia.
  6. The study should include a cumulative adverse event rate.
  7. The premarket study should be 300 patients followed from pre-operative status to 3 years and post-market study should be conducted for 5 years.
  8. Pre-market substudies should include, functional performance, contrast sensitivity, endothelial cell evaluation.
  9. A criteria should be established for combined near and distance uncorrected visual acuity.
  10. An appropriate questionnaire should be administered to evaluate all patients to include questions related to night vision, night driving, reading, etc.

Contact: Sara M. Thornton, Executive Secretary
(301) 594-2053, ext.127; e-mail smt@cdrh.fda.gov

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(202) 546-6666
or
Food and Drug Administration
Freedom of Information Staff (FOI)
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Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

EXECUTIVE SUMMARY MAY BE PURCHASED FROM:
(Written Request Only)
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

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Updated March 10, 2004

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