Treatment outcomes in the DRy Eye Amniotic Membrane (DREAM) study

Marguerite B McDonald, Hosam Sheha, Sean Tighe, Susan B Janik, Frank W Bowden, Amit R Chokshi, Michael A Singer, Seema Nanda, Mujtaba A Qazi, Damon Dierker, Adam T Shupe, Brittany J McMurren, Marguerite B McDonald, Hosam Sheha, Sean Tighe, Susan B Janik, Frank W Bowden, Amit R Chokshi, Michael A Singer, Seema Nanda, Mujtaba A Qazi, Damon Dierker, Adam T Shupe, Brittany J McMurren

Abstract

Purpose: To evaluate the efficacy of cryopreserved amniotic membrane (CAM) in reducing signs and symptoms of dry eye disease (DED) in a large patient population.

Methods: A retrospective chart review at 10 clinical sites was done of patients with refractory DED who received CAM and completed at least 3 months of follow-up. Data collected were demographics; medical history including previous and current ocular treatment, diagnosis, clinical presentations, comorbidity, duration and frequency of treatment with CAM; and concomitant medications. The primary outcome was the change in dry eye workshop (DEWS) score after treatment.

Results: A total of 97 eyes of 84 patients exhibited severe dry eye despite maximal medical treatments including topical artificial tears, cyclosporine-A, serum, antibiotics, and steroids. Patients manifested with superficial punctate keratitis (86%), filamentary keratitis (13%), exposure keratitis (19%), neurotrophic keratitis (2%), and corneal epithelial defect (7%). After CAM treatment for 5.4±2.8 days, 74 (88%) patients demonstrated an improved ocular surface along with a notable reduction of the severity as the overall DEWS score was significantly reduced from 3.25±0.5 at baseline to 1.44±0.6 at 1 week, 1.45±0.6 at 1 month, and 1.47±0.6 at 3 months (p<0.001). Ten eyes (10%) required repeated treatment to complete healing. Apart from discomfort during CAM placement, there were no adverse events.

Conclusion: Placement of CAM is promising to enhance the recovery of ocular surface health and reduce signs and symptoms in patients with moderate-to-severe DED.

Keywords: DEWS; amniotic membrane; dry eye; ocular surface; severity.

Conflict of interest statement

Disclosure Dr McDonald and Dr Nanda are consultants and members of the speaker bureau of Bio-Tissue Inc., that distributes PROKERA®. Dr Sheha and Mr Tighe are employees of TissueTech Inc. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Case representatives: Self-retained CAM for severe DED. Notes: A case of severe DED with DEWS score =4 after Rose Bengal (A) and fluorescein staining (B). After receiving CAM for 5 days, the inflammation was markedly reduced, the ocular surface healed completely, and remained stable for 3 months (C, D). Abbreviations: CAM, cryopreserved amniotic membrane; DED, dry eye disease; DEWS, dry eye workshop.
Figure 2
Figure 2
Changes of DEWS score. Note: DEWS score was significantly reduced from 3.25±0.5 to 1.44±0.6 at 1 week, 1.45±0.6 at 1 month, and 1.47±0.6 at 3 months (p<0.001). Abbreviation: DEWS, dry eye workshop.

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