Ana G. Alzaga Fernandez, M.D., Samir A. Shah, M.D., M.S.Ana G. Alzaga Fernandez, M.D., Samir A. Shah, M.D., M.S.

Department of Ophthalmology and Eye Care Services, Department of Ophthalmology and Eye Care Services, Henry Ford Hospital, Detroit, MI.Henry Ford Hospital, Detroit, MI.

Beach Eye Medical Group, Huntington Beach, CA.Beach Eye Medical Group, Huntington Beach, CA.

Improvement in corneal scarring after Improvement in corneal scarring after removal of intracorneal lensremoval of intracorneal lens

The authors have no financial interest in the subject matter of this poster.

AbstractAbstract Purpose:Purpose:  To report a case of improved corneal scarring and vision after removal of a   To report a case of improved corneal scarring and vision after removal of a

PermaVision intracorneal lens.PermaVision intracorneal lens.

Methods:Methods:  After adequately determining the patient’s candidacy for the placement of an   After adequately determining the patient’s candidacy for the placement of an intracorneal lens, the underwent PermaVision intracorneal lens placement in the left eye intracorneal lens, the underwent PermaVision intracorneal lens placement in the left eye uneventfully in June 14, 2004. Corneal scarring was noted five years later and a medical uneventfully in June 14, 2004. Corneal scarring was noted five years later and a medical regimen consisting of topical steroid drops was initiated. Due to limited improvement with regimen consisting of topical steroid drops was initiated. Due to limited improvement with the medical regimen, on April 22, 2010, the intracorneal lens was removed.the medical regimen, on April 22, 2010, the intracorneal lens was removed.

Results:Results:  At one month after the initial placement of the PermaVision intracorneal lens, the   At one month after the initial placement of the PermaVision intracorneal lens, the patient’s uncorrected visual acuity was 20/20 with minimal peripheral haze. After five patient’s uncorrected visual acuity was 20/20 with minimal peripheral haze. After five years, the uncorrected visual acuity had reduced to 20/60 and the best-corrected visual years, the uncorrected visual acuity had reduced to 20/60 and the best-corrected visual acuity to a subjectively blurry 20/30. She was found to have intrastromal scarring under acuity to a subjectively blurry 20/30. She was found to have intrastromal scarring under the corneal flap overlying the implant. Topical corticosteroid therapy provided limited the corneal flap overlying the implant. Topical corticosteroid therapy provided limited improvement. The intracorneal lens was removed uneventfully. In the first postoperative improvement. The intracorneal lens was removed uneventfully. In the first postoperative day, the patient’s uncorrected visual acuity was 20/40. At one month and subsequently at day, the patient’s uncorrected visual acuity was 20/40. At one month and subsequently at three months after the procedure, the patient’s best-corrected visual acuity was 20/30 with three months after the procedure, the patient’s best-corrected visual acuity was 20/30 with minimal residual intrastromal haze. The patient noted a substantial subjective visual minimal residual intrastromal haze. The patient noted a substantial subjective visual improvement.improvement.

Conclusion:Conclusion:  Intracorneal lenses, such as PermaVision, should be cautiously used for   Intracorneal lenses, such as PermaVision, should be cautiously used for treatment of hyperopia. Patients receiving these implants require long-term follow-up as treatment of hyperopia. Patients receiving these implants require long-term follow-up as scarring and a decline in best-corrected visual acuity can develop several years after scarring and a decline in best-corrected visual acuity can develop several years after surgery. Fortunately, removal of the intracorneal lens can provide visual improvement surgery. Fortunately, removal of the intracorneal lens can provide visual improvement even years after the original surgery.even years after the original surgery.

IntroductionIntroduction Keratophakia is a procedure to correct vision by inserting a lenticule in Keratophakia is a procedure to correct vision by inserting a lenticule in

the corneal stroma. Barraquer performed thousands of keratophakia the corneal stroma. Barraquer performed thousands of keratophakia procedures using donor corneal tissue and synthetic stromal inlays.procedures using donor corneal tissue and synthetic stromal inlays.11

The importance of water and nutrient movement across the cornea from The importance of water and nutrient movement across the cornea from the aqueous humor led to the development of hydrogel hydroxyethyl the aqueous humor led to the development of hydrogel hydroxyethyl methacrylate implants which increase the solute permeability.methacrylate implants which increase the solute permeability.2-32-3

The hydrogel lenses (Permalens), with a water content of 71%, proved The hydrogel lenses (Permalens), with a water content of 71%, proved to have excellent tissue bioavailability in non-human primates. However, to have excellent tissue bioavailability in non-human primates. However, glucose transport decreased with greater implant thicknesses.glucose transport decreased with greater implant thicknesses.44

Fenestrated hydrogel intracorneal implants (PermaVision) were Fenestrated hydrogel intracorneal implants (PermaVision) were developed to address these limitations. These lenses, which are developed to address these limitations. These lenses, which are composed of more than 70% water content and have a refractive index composed of more than 70% water content and have a refractive index close to 1.376, were designed to correct hyperopia up to +6 diopters close to 1.376, were designed to correct hyperopia up to +6 diopters (D). The refractive effect of the lens is achieved through the alteration (D). The refractive effect of the lens is achieved through the alteration of the corneal shape.of the corneal shape.5-85-8

We report a clinical complication after five years of PermaVision We report a clinical complication after five years of PermaVision intracorneal lens placement and recommended intervention. intracorneal lens placement and recommended intervention.

PurposePurpose To report a case of improved corneal scarring and vision To report a case of improved corneal scarring and vision

after removal of a PermaVision intracorneal lens.after removal of a PermaVision intracorneal lens.

After adequately determining the patient’s candidacy for After adequately determining the patient’s candidacy for the placement of an intracorneal lens, the underwent the placement of an intracorneal lens, the underwent PermaVision intracorneal lens placement in the left eye PermaVision intracorneal lens placement in the left eye uneventfully in June 14, 2004. Corneal scarring was uneventfully in June 14, 2004. Corneal scarring was noted five years later and a medical regimen consisting noted five years later and a medical regimen consisting of topical steroid drops was initiated. Due to limited of topical steroid drops was initiated. Due to limited improvement with the medical regimen, on April 22, improvement with the medical regimen, on April 22, 2010, the intracorneal lens was removed.2010, the intracorneal lens was removed.

Methods and MaterialsMethods and Materials

Case ReportCase Report A 53-year-old Caucasian lady with a history of PermaVision intracorneal lens A 53-year-old Caucasian lady with a history of PermaVision intracorneal lens

placement in the left eye in June 14, 2004 began with significant worsening of placement in the left eye in June 14, 2004 began with significant worsening of her vision at distance and near within the last year. Her cycloplegic refraction her vision at distance and near within the last year. Her cycloplegic refraction in the left eye preoperatively was: +2.25 +0.25 x 180 degrees with a visual in the left eye preoperatively was: +2.25 +0.25 x 180 degrees with a visual acuity of 20/16. At near, with +2.25 add, her vision was 20/20. She was acuity of 20/16. At near, with +2.25 add, her vision was 20/20. She was found to be left eye dominant. Her central corneal thickness in the same eye found to be left eye dominant. Her central corneal thickness in the same eye was 521 microns and in the periphery was 599 microns. Her keratometry was 521 microns and in the periphery was 599 microns. Her keratometry measurement in the left eye was: 45.25/46.25 x 166 degrees. measurement in the left eye was: 45.25/46.25 x 166 degrees.

One week postoperatively, her best-corrected visual acuity was 20/25 with the One week postoperatively, her best-corrected visual acuity was 20/25 with the following refraction: -0.75 sphere. A month afterwards, her best corrected following refraction: -0.75 sphere. A month afterwards, her best corrected visual acuity was 20/16 with the following refraction: +0.75 +1.00 x 5 degrees. visual acuity was 20/16 with the following refraction: +0.75 +1.00 x 5 degrees. Trace haze at the edge of the flap was noted from four to eleven o’clock.Trace haze at the edge of the flap was noted from four to eleven o’clock.

Case ReportCase Report After five years, the patient was unsatisfied with her After five years, the patient was unsatisfied with her

vision at a distance and at near and subjectively vision at a distance and at near and subjectively complained of blur. Her best-corrected visual acuity was complained of blur. Her best-corrected visual acuity was 20/30 and her cycloplegic refraction was -0.50 +0.50 x30 20/30 and her cycloplegic refraction was -0.50 +0.50 x30 degrees. On slit lamp exam, she had superficial scarring degrees. On slit lamp exam, she had superficial scarring on the flap overlying the implant and was started on on the flap overlying the implant and was started on topical steroids without improvement. topical steroids without improvement.

The patient underwent on April 22, 2010 removal of the The patient underwent on April 22, 2010 removal of the implant. In the first postoperative day, the patient’s implant. In the first postoperative day, the patient’s uncorrected visual acuity was 20/40. At one month and uncorrected visual acuity was 20/40. At one month and subsequently at three months after the procedure, the subsequently at three months after the procedure, the patient’s best-corrected visual acuity was 20/30 with patient’s best-corrected visual acuity was 20/30 with minimal residual intrastromal haze. The patient noted a minimal residual intrastromal haze. The patient noted a substantial subjective visual improvement.substantial subjective visual improvement.

ResultsResults

Five years after PermaVision intracorneal lens Five years after PermaVision intracorneal lens placement, the patient’s best-corrected visual placement, the patient’s best-corrected visual acuity was 20/30.acuity was 20/30.

Due to corneal scarring overlying the implant, Due to corneal scarring overlying the implant, the patient was started on topical corticosteroid the patient was started on topical corticosteroid therapy as initial medical intervention with therapy as initial medical intervention with minimal improvement.minimal improvement.

Surgical removal of the implant was performed Surgical removal of the implant was performed with subjective improvement of visual acuity and with subjective improvement of visual acuity and minimal residual intrastromal haze.minimal residual intrastromal haze.

External and Slit Lamp Photographs of the Left EyeExternal and Slit Lamp Photographs of the Left EyePermaVision Intracorneal Lens 5 years

after placementPermaVision Intracorneal Lens 3 months

after removal

OCT of the Anterior Segment OCT of the Anterior Segment

4/19/10 4/30/10

Prior to removal of implant After removal of implant

DiscussionDiscussion The concept of synthetic intracorneal implants or inlays has been investigated for over 40 The concept of synthetic intracorneal implants or inlays has been investigated for over 40

years by Barraquer in 1964.years by Barraquer in 1964.11

The new generation of soft intracorneal lenses, such as PermaVision intracorneal lenses, The new generation of soft intracorneal lenses, such as PermaVision intracorneal lenses, are an alternative for the correction of hyperopia.are an alternative for the correction of hyperopia.77

The complications experienced in previous models for this type of implant are anterior The complications experienced in previous models for this type of implant are anterior stromal edema, recurrent epithelial erosion, and neovascularization.stromal edema, recurrent epithelial erosion, and neovascularization. 3,5,73,5,7

In vivo confocal microscopy has shown significant keratocyte activation, diffuse In vivo confocal microscopy has shown significant keratocyte activation, diffuse extracellular deposits, decreased keratocyte density posterior to the intracorneal lens, and extracellular deposits, decreased keratocyte density posterior to the intracorneal lens, and reduced epithelial thickness. The abnormal keratocyte activation suggests mechanical reduced epithelial thickness. The abnormal keratocyte activation suggests mechanical stress on the tissue or altered cytokine production from the metabolically stressed stress on the tissue or altered cytokine production from the metabolically stressed epithelial and stromal cells. epithelial and stromal cells. 9,109,10

Corneal sensitivity was markedly reduced in a series of patients 6 months after lens Corneal sensitivity was markedly reduced in a series of patients 6 months after lens placement.placement.88

The depth of lens placement may play a role in the biocompatibility of the lens and its The depth of lens placement may play a role in the biocompatibility of the lens and its predictability. In a primate model, placing the lenses at one third to 60% depth achieved predictability. In a primate model, placing the lenses at one third to 60% depth achieved optimal results. optimal results. 8,118,11

Follow-up studies have been conducted up to two years after lens placement in human Follow-up studies have been conducted up to two years after lens placement in human sighted eyes. Some studies suggest these lenses provide a stable and predictable way to sighted eyes. Some studies suggest these lenses provide a stable and predictable way to correct moderate hyperopia.correct moderate hyperopia.77 However, stromal opacification, decentration, decrease in However, stromal opacification, decentration, decrease in visual acuity, night halos and glare occurred in several patients.visual acuity, night halos and glare occurred in several patients. 77 Other trials, due to Other trials, due to suboptimal results in their studies, recommend further research to improve the safety and suboptimal results in their studies, recommend further research to improve the safety and quality of refractive outcomes with these devices.quality of refractive outcomes with these devices.88

ConclusionsConclusions

Intracorneal lenses, such as PermaVision, Intracorneal lenses, such as PermaVision, should be cautiously used for treatment of should be cautiously used for treatment of hyperopia. Patients receiving these implants hyperopia. Patients receiving these implants require long-term follow-up as scarring and a require long-term follow-up as scarring and a decline in best-corrected visual acuity can decline in best-corrected visual acuity can develop several years after surgery. develop several years after surgery. Fortunately, removal of the intracorneal lens Fortunately, removal of the intracorneal lens can provide visual improvement even years can provide visual improvement even years after the original surgery.after the original surgery.

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7.7. Ismail MM: Correction of hyperopia by intracorneal lenses. Two year follow-up. J Cataract Ismail MM: Correction of hyperopia by intracorneal lenses. Two year follow-up. J Cataract Refract Surg. 2006;32:1657-60.Refract Surg. 2006;32:1657-60.

8.8. Verity SM, McCulley JP, Bowman RW, et al: Outcomes of PermaVision intracorneal implants Verity SM, McCulley JP, Bowman RW, et al: Outcomes of PermaVision intracorneal implants for the correction of hyperopia. Am J Ophthalmol. 2009;147:973-7.for the correction of hyperopia. Am J Ophthalmol. 2009;147:973-7.

9.9. Petroll WM, Goldberg D, Lindsey SS, et al: Confocal assessment of the corneal reponse to Petroll WM, Goldberg D, Lindsey SS, et al: Confocal assessment of the corneal reponse to intracorneal lens insertion and laser in situ keratomileusis with flap creation using Intralase. J intracorneal lens insertion and laser in situ keratomileusis with flap creation using Intralase. J Cataract Refract Surg. 2006;32:1119-28.Cataract Refract Surg. 2006;32:1119-28.

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