Purpose
To review the effectiveness of continuous or extended daily wear of Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) for treating recurrent or persistent corneal epithelial defects from a variety of causes that were refractory to conventional therapy in 9 patients.
Design
Retrospective case series.
Methods
The medical records of 9 patients with a history of recurrent or persistent corneal epithelial defects resistant to conventional medical treatment who received treatment at the Cullen Eye Institute between January 2011 and July 2012 were reviewed. Demographic information, etiology, prior treatment, and outcome of PROSE treatment were analyzed. Recurrence after cessation of PROSE and complications were also identified.
Results
The etiologies of recurrent or persistent corneal epithelial defects in this series included neurotrophic keratopathy, lattice and Avellino dystrophy, Stevens-Johnson syndrome, and chemical/thermal injury. All patients were initially treated with bandage contact lens; however, continuous silicone hydrogel lens wear was not effective in preventing recurrence or healing corneal epithelial defects in all patients. Epithelial defects healed without recurrence in all 9 patients treated with PROSE. Eight patients developed recurrent epithelial defects when PROSE was discontinued, but rehealed after resuming PROSE. Visual acuity improved in 8 patients (88.9%) treated with PROSE.
Conclusions
Complex persistent or recurrent corneal epithelial defects that failed to heal with extended silicone hydrogel contact lenses healed with PROSE. PROSE therapy was well tolerated, but corneal epithelial defects recurred in all but 1 case following cessation of therapy.
Epithelial adherence is essential for corneal epithelial wound healing. In conditions such as primary epithelial basement membrane disease, Bowman layer or stromal dystrophies, neurotrophic keratopathy, and corneal edema, the corneal epithelium may have weak adherence to the basement membrane and consequently heal poorly or be dislodged with physiological trauma. Additionally, corneal epithelial integrity may be compromised by blink trauma from irregular and/or keratinized lids and tarsal conjunctiva developing after chemical/thermal burn or Stevens-Johnson syndrome. In the presence of these corneal and ocular surface diseases, epithelial defects can often be persistent and nonhealing, or recur despite conventional therapy.
Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE), previously known as the Boston Ocular Surface Prosthesis (BOSP), is a custom-designed prosthetic approved by the Food and Drug Administration. It is a fluid-ventilated gas-permeable prosthetic device that vaults overs the cornea and immerses the entire corneal surface in a reservoir of fluid. PROSE has been used for rehabilitation of a variety of ocular surface disorders. This study describes daily or continuous wear of PROSE to successfully treat complex recurrent or persistent epithelial defects that were refractory to conventional treatment in 9 patients with corneal epithelial defects attributable to a variety of causes, including stromal dystrophies, chemical/thermal burn, Stevens-Johnson syndrome, and neurotrophic keratopathy.
Patients and Methods
This retrospective medical record review on “PROSE for the treatment of epithelial defects resistant to treatment with extended wear soft contact lens” was approved by the Baylor College of Medicine Institutional Review Board. The research protocol adhered to the tenets of the Declaration of Helsinki for clinical research.
Study Population
The medical records of 9 patients (9 eyes) treated with PROSE between January 2, 2011 and July 31, 2012 at the Alkek Eye Center of Cullen Eye Institute at Baylor College of Medicine with a history of persistent or recurrent corneal epithelial defects resistant to conventional medical treatment were reviewed. Information regarding the etiology, prior treatments, number of recurrences, and outcome of therapy were recorded.
Daily or Continuous PROSE Wear
Patients were fitted with PROSE and instructed to wear the device filled with Unisol preservative-free saline (Alcon, Fort Worth, Texas, USA), with or without 1 drop of moxifloxicin 0.3% (Alcon). For continuous PROSE wear, lenses were removed, cleaned, and reinserted daily by the patients or doctors; for daily wear, lenses were worn for 16 hours daily during waking hours. Initially, all patients but 1 were instructed to wear PROSE continuously, while 1 patient was instructed to wear PROSE daily because of corneal edema. Another patient was later switched to daily wear because corneal edema developed during the continuous wear.
Patients were reevaluated at 1- or 2-day intervals during the first week of continuous wear.
Results
The Table summarizes demographic information, etiology, prior treatment, and clinical outcome.
| Patient No. | Diagnosis | Age/Sex | Prior Treatment | No. of Recurrences After PROSE Discontinuation | Pretreatment Visual Acuity | Final Visual Acuity | PROSE Regimen | Outcome at Last Examination | Length of Follow-up | Complications of PROSE |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Neurotrophic keratopathy, secondary recurrent erosion | 81/male | BSCL, PTK, AMT | 3 | 20/200 | 20/30 | Continuous PROSE wear a | Epithelium healed | 6 mo | |
| 2 | Neurotrophic keratopathy, secondary recurrent erosion | 44/male | BSCL, AMT, tarsorraphy | 6 | Count fingers at 2 ft | 20/40 | Continuous PROSE wear a | Epithelium healed | 5 mo | |
| 3 | Neurotrophic keratopathy, secondary recurrent erosion | 87/female | BSCL | 1 | 20/400 | 20/60 | Continuous PROSE wear a | Epithelium healed | 4 mo | |
| 4 | Neurotrophic keratopathy, secondary recurrent erosion | 85/male | BSCL, lubricant drops | 0 | 5/200E | 20/200 | Continuous PROSE wear a | Epithelium healed | 9 mo | |
| 5 | Avellino stromal dystrophy, primary recurrent erosion | 74/male | BSCL, multiple PKPs | 5 | 20/200 | 20/40 | Daily PROSE wear and BSCL at night | Epithelium healed | 3 mo | |
| 6 | Lattice stromal dystrophy, primary recurrent erosion | 66/female | BSCL, multiple PKPs | 1 | 20/200 | 20/100 | Continuous PROSE wear a | Epithelium healed | 15 mo | |
| 7 | Stevens-Johnson syndrome, secondary recurrent erosion | 54/male | PKP, mucous membrane graft, fornix reconstruction, AMT, BSCL | 4 | 20/80 | 20/80 | Continuous PROSE wear a | Epithelium healed | 6 mo | Multiple fungal keratitis and mycobacterial keratitis |
| 8 | Hot water and chlorine injury, secondary recurrent erosion | 40/male | BSCL, lubricant drops | 1 | 20/400 | 20/200 | Continuous PROSE wear a | Epithelium healed | 3 mo | |
| 9 | Acetic acid injury, secondary recurrent erosion | 37/male | LSCT, KLAT, tarsorrhaphy, Avastin injection, PKP, BSCL | 6 | 20/200 | 20/40 | Daily PROSE wear and BSCL at night | Epithelium healed | 5 mo |
a PROSE wear during sleeping and waking hours; lenses were removed, cleaned, and reinserted daily by the patient or doctors.
Nine subjects with complex persistent or recurrent corneal epithelial defects attributable to poor epithelial adherence secondary to neurotrophic keratopathy (n = 4) or stromal dystrophies (lattice n = 1, Avellino n = 1) or rough and irregular eyelids and superior tarsal conjunctiva secondary to Stevens-Johnson syndrome (n = 1) or chemical/thermal injuries (n = 2) were treated with PROSE. Four of the patients had a history of 1 or more penetrating keratoplasty (PKP), 1 patient had a mucous membrane graft, and 1 received 2 keratolimbal allografts (KLAT). Prior treatment of persistent or recurrent epithelial erosions in these patients included amniotic membrane transplantation (AMT) in 3, phototherapeutic keratectomy (PTK) in 1, and lateral tarsorrhaphy in 2. All patients were also treated with silicone hydrogel contact lens for an average of 2 months of continuous wear (range 2 weeks to 3 months). The corneal epithelial defects remained in all patients despite these conventional treatments.
Subjective and objective improvement was observed after treatment with PROSE in all patients. Epithelial defects healed within 1 month of starting PROSE in all 9 patients. Eight patients experienced recurrent corneal epithelial defects following cessation of PROSE treatment. Visual acuity improved in 8 patients treated with PROSE. The patients were followed up for an average of 6 months (range 3-15 months).
Figures 1 and 2 show representative images from 2 patients who failed to heal with continuous silicone hydrogel contact lens wear but who healed with PROSE.
