Perioperative intense pulsed light to prevent and improve symptoms of post-laser corneal refractive surgery dry eye. A randomized clinical trial.

PURPOSE: To evaluate the efficacy of perioperative IPL therapy in preventing postoperative ocular surface disorders in patients undergoing corneal laser refractive surgery. DESIGN: randomized, controlled, clinical trial with triple-blinding. METHODS: Setting: Vissum Miranza - Alicante; Study population: 61 patients randomized in two groups: 31 study patients (perioperative IPL + laser refractive surgery) and 30 control patients (perioperative placebo + laser refractive surgery). Follow-up was conducted over a 6-month period; Intervention: Each participants underwent three IPL sessions with a two-week interval between each session (pre-surgery, post-surgery week-one, and post-surgery week-three). For controls, placebo was administered following the same protocol. MAIN OUTCOMES MEASURES: visual outcomes and refraction, slit-lamp examination, corneal topography, visual analogue scale questionnaire and Oculus Keratograph 5 M including tear meniscus height, non-invasive tear break- up time, ocular redness, infrared meibography and Ocular Surface Disease Index (OSDI) questionnaire. RESULTS: 61 randomized eyes were included. No significant differences were observed in terms of uncorrected and corrected distance visual acuity (UDVA, CDVA), refractive error or corneal aberrations. A statistically significant improvement in OSDI score (change -8.47, p = 0.043), tear meniscus (change 0.05 mm, p = 0.004) and Meibography (change -0.42, p = 0.012) was observed at the third postoperative month in the study group. Additionally, at the sixth postoperative month, there were statistically significant improvements in tear meniscus (change 0.06 mm, p = 0.018), tear break-up-time (change 1.68 s, p = 0.039) and Meibography (change -0.37, p = 0.030). CONCLUSIONS: Results suggest that perioperative IPL therapy applied to laser corneal refractive surgery improves objective and subjective ocular surface parameters over non-IPL-treated control patients and early postoperative dry eye symptoms.

Comparative Analysis of Strabismus Measurement Using a Video Oculagraphy System and Alternate Prism Cover Test.

PURPOSE: The aim of the study was to compare distance vision measurements obtained with video oculography (VOG) and an alternate prism cover test (APCT). DESIGN: Single-center, retrospective, and cross-sectional. METHODS: Eighty-seven subjects with strabismus were included. All patients underwent an optometric examination. The measurement of strabismus in distance vision was performed with the best optical correction using the APCT and the VOG GazeLab. Subjects were divided according to the type of strabismus; 41 were esotropic and 46 were exotropic. RESULTS: The general comparison of APCT and VOG showed a mean difference of 0.60±2.74 prism diopters (Δ), not observing statistical differences between both methods ( P =0.059) and presenting a correlation of 0.976 ( P <0.001). Using APCT, the mean amount of esotropia for the group was 18.31±11.64 Δ and that of exotropia was 19.62±8.80 Δ. Compared with the VOG, the mean value of esotropia for the group was 18.65±11.65 Δ and that of exotropia was 19.48±8.62 Δ. The means are statistically different for the esotropia group ( P =0.005) but not for the exotropia group ( P =0.318). There was a high direct correlation between the methods of measurement for both the esotropic ( R =0.980; P <0.001) and exotropic patients ( R =0.975; P <0.001). Bland-Altman analysis shows a mean difference of 1.37±2.76 Δ for the esotropia patients and 0.31±2.66 Δ for the exotropic patients, respectively. CONCLUSIONS: This study demonstrated comparable results in measuring strabismus between VOG and APTC for esotropia and exotropia, with an excellent correlation between both methods and good agreement, especially in subjects with exotropia.

Efficacy and safety of intense pulsed light of upper and lower eyelids in Meibomian gland dysfunction: A prospective multicentric study.

PURPOSE: To demonstrate that intense pulsed light therapy (IPL) of the upper and lower eyelids with meibomian gland expression (MGX) is effective in improving dry eye disease due to meibomian gland dysfunction (MGD). METHODS: Patients with ocular discomfort (Ocular Surface Disease Index -OSDI- above 13) and signs of MGD were recruited. All patients underwent OSDI, visual acuity (VA), intraocular pressure, Schirmer test, meibography, non-invasive tear breakup time (NITBUT), slit-lamp examination (corneal and conjunctival staining, hyperemia, gland expressibility, and meibum quality), tear osmolarity and lipid layer thickness. IPL was performed with Optima IPL (Lumenis Ltd.) following a standardized protocol on upper and lower eyelids of both eyes, with inferior eyelid MGX. Patients received four sessions separated by two weeks each. Four weeks after, examinations were repeated. RESULTS: 160 patients (320 eyes) were included, of which 108 (67.5%) were women and mean age was 59.2 ± 15.08 (range 20-89). After four sessions, VA, OSDI, tear osmolarity, lipid layer thickness, NITBUT, hyperemia, corneal and conjunctival staining, gland expressibility, meibum quality, inferior eyelid Meiboscore and Schirmer test improved (all, p < 0.027). Changes in OSDI, initial and average NITBUT increased with dry eye disease severity (according to OSDI). Increased pre-treatment OSDI, hyperemia, corneal and conjunctival staining and Schirmer test were associated with an improvement in OSDI (all, p < 0.040). No adverse events were noted. CONCLUSIONS: The combination of IPL on upper and lower eyelids with MGX is safe and effective for the treatment of MGD. Patients with severe dry eye disease present greater improvements.

Efficacy and safety of intense pulsed light direct eyelid application.

To describe the efficacy and safety of intense pulsed light (IPL) applied directly on the eyelids of patients with Meibomian gland dysfunction (MGD) without corneal shield protector. Observational retrospective single centre study where patients underwent 3 treatment sessions of IPL with 2 weeks of interval. The IPL was carried out with Lumenis OPT M22 with a double pass technique of 12 impacts on the infraorbital/lower eyelid region with the 15 × 35 mm guide light (step 1) and a double pass technique of 3 impacts over the upper eyelids with the 8 × 15 mm guide light (step 2). The follow up was conducted through Oculus Keratograph 5 M. 30 patients were enrolled in the study. Although there were no significant differences (p > 0.05), non-invasive tear break-up time, ocular redness, and OSDI questionnaire improved during the 3 IPL sessions. A significant improvement (p = 0.024) in the percentage of meibomian gland loss was also observed. Regarding tear meniscus, it was found similar measurements before and after treatment. No serious adverse effects were reported during the procedure or in subsequent follow-up. Preliminary results suggest that IPL therapy applied directly on the eyelids without corneal shield could be safe and effective in the treatment of MGD.

Cosmetic Keratopigmentation in Sighted Eyes: Medium- and Long-term Clinical Evaluation.

PURPOSE: To assess the medium- and long-term outcomes of keratopigmentation (KTP) as a surgical alternative to change the cosmetic appearance of healthy eyes. METHODS: A prospective, interventional, consecutive, multicenter, series of cases of cosmetic KTP was included in the study. Forty consecutive patients underwent KTPs with mineral micronized pigments using a femtosecond laser-assisted intrastromal or superficial technique. Main outcomes were cosmetic evaluation, subjective patients' satisfaction, and complications. The outcomes were evaluated at 6 months after the last operation and then yearly. RESULTS: This study included 79 eyes of 40 patients, with a mean age of 34 ± 11 years; femtosecond laser-assisted intrastromal keratopigmentation was performed in 39 patients (97.5%) and superficial automated keratopigmentation in 1 patient. Mean follow-up was 29 months (range 6-69). Observer's evaluation was excellent in 90% of cases, and patient's satisfaction was excellent in 92.5% of cases. Twenty-eight eyes (35.4%) were reoperated; of them, 7 eyes (8.9%) had 2 color touch ups and 4 eyes (5.1%) had 3 color touch ups. After the retreatments, all the patients were satisfied with the cosmetic aspect. Light sensitivity at first month was the most common complication (30%), followed by change in the color (7.5%), color fading (5%), and visual field limitations in a case with 4.5-mm pupil size (2.5%). One patient with a previous laser in situ keratomileusis developed corneal ectasia. CONCLUSIONS: Cosmetic KTP achieves good cosmetic results and is associated with high patient satisfaction. Most of the complications could be managed adequately. It might offer a safe and effective new surgical alternative for those patients motivated to change the apparent color of their eyes.

COVID-19 Disease and Ophthalmology: An Update.

The worldwide outbreak of the severe and acute respiratory coronavirus disease (COVID-19) caused by the coronavirus strain SARS-CoV-2 is currently the focal point of discussion due to the suffering this syndrome is causing to humanity. However, the ophthalmological implications of this syndrome has not yet been well described. Both eyes and tears as portals of entry and sources of contagion have been the subject of debate by many authors. The purpose of this review is to summarize the evidence currently available on COVID-19 and its ocular implications and manifestations, in both animals and humans, with the aim to facilitate prevention and educate the ophthalmological community on this subject. A review of the literature revealed that the results of some studies suggest that ocular symptoms commonly appear in patients with severe COVID-19 pneumonia and that it is possible to isolate the virus from the conjunctival sac of these patients. Conjunctivitis is not a common manifestation of the disease, but contact with infected eyes could be one route of transmission. Consequently, ophthalmologists need to have correct prevention strategies in place. Some guidelines regarding the prevention and management of ophthalmology clinics are reviewed. However, well-designed trials should be conducted to rule out other ocular manifestations that may result from COVID-19 infection and to understand the transmission of the virus through the eyes.

Keratopigmentation combined with strabismus surgery to restore cosmesis in eyes with disabling corneal scarring and squint.

BACKGROUND: Therapeutic corneal pigmentation has modernly evolved into different sophisticated techniques to camouflage cosmetically disabling corneal opacities and scars with good reported outcomes. Blind eyes frequently suffer from strabismus which further deteriorates the cosmesis of the patient. Combined keratopigmentation (KTPG) with strabismus surgery may be an option for these patients. METHODS: A total of 72 consecutive patients were retrospectively reviewed in this investigation. Main outcome measures were postoperative residual squint, and cosmesis evaluated by an independent observer, patient satisfaction, reoperation rates for KTPG and squint, and complications. RESULTS: A total of 72 consecutive patients and 73 eyes that underwent KTPG and strabismus surgery were included in this study. Mean follow-up time was 2.5±3 years. Patient age ranged from 5 to 83 years, with 93% having visual acuity worse than 0.1. 14 eyes (24.5%) underwent repeated KTPG, 24 (42.1%) had repeated strabismus surgery. 14 patients (19.4%) had a repeat muscle surgery, although 55 (76.4%) of the 72 patients achieved orthotropia or had deviations within 10 prism dioptres at the end of the follow-up period. Corneal microperforation was encountered in two (2.8%) patients and conjunctival staining in 10 eyes. Cosmesis was good for all patients. Patients who required repeat KTPG or strabismus surgery, or those in whom orthotropia was not totally restored, considered their cosmetic appearance sufficiently improved. CONCLUSION: Corneal KTPG combined with strabismus surgery provides good cosmesis for patients with corneal scarring and strabismus with minimal complications. Reoperation rates are relatively high in the short term to accomplish an optimal cosmetic result.

Superficial Keratopigmentation: An Alternative Solution for Patients With Cosmetically or Functionally Impaired Eyes.

PURPOSE: To report the use of different superficial keratopigmentation (KTP) techniques for restoring or enhancing cosmetic appearance of eyes impaired for several reasons. METHODS: This is a retrospective, consecutive, noncomparative interventional series of cases, in which 136 cosmetically disabled eyes (due to different corneal abnormalities) of 130 patients were included. A total of 222 procedures of superficial manual KTP and superficial automated KTP were performed. The procedures were divided into 2 groups: first and second-stage procedures. The patients' cosmetic appearance and satisfaction were evaluated and graded as excellent, good, or poor. RESULTS: A total of 222 procedures were performed, 57.2% were superficial automated KTP, 22.5% were superficial manual KTP, and 20.3% included the combination of superficial KTP with other KTP techniques. Six procedures were purely cosmetic, 16 therapeutic functional, and 200 therapeutic cosmetic. Superficial KTP, as a second-stage procedure, was performed in 13 eyes that were previously pigmented by intrastromal techniques. Superficial KTP as an initial indication (first-stage procedure) alone or in combination with another KTP technique in the same surgery was performed in 123 eyes, in which 44.7% of them were reoperated once or more. Best-corrected visual acuity changed insignificantly, and the intraocular pressure decreased significantly in all the studied groups. No intraoperative complications were observed, 11.2% of eyes with a follow-up time of more than 3 months developed postoperative complications. Most of the patients (98.5%) were satisfied. CONCLUSIONS: The modern superficial KTP procedure provides the possibility to improve the cosmetic appearance of impaired eyes, as an alternative to evisceration, enucleation, prosthetic contact lenses, or keratoplasty.

Keratopigmentation with micronised mineral pigments: complications and outcomes in a series of 234 eyes.

AIM: To report the complications observed in a consecutive large series of cases treated with keratopigmentation (KTP). METHODS: KTP was performed in 234 eyes of 204 patients for therapeutic and cosmetic reasons. From them, 50 eyes of 29 patients suffered complications. Different KTP techniques and three generations of pigments (GP) were used. The follow-up period ranged from 4 months to 12 years. Light sensitivity (LS), visual field (VF) limitations and MRI alterations were considered functional complications. Organic complications were described as change in colour, colour fading and neovascularisation. RESULTS: The percentage of complications was 12.82%. Most patients complained of LS (49%), then colour fading and change in colour (19%). Neovascularisation, VF limitations and MRI complications constituted 7%, 4% and 2%, respectively. Organic complications were observed with the previous GP but resolved with the latest third GP with CE mark certification (Conformité Européene). Although LS remained with the corneal-specific pigments, it gradually disappeared in most of the patients (81.81%) 6 months postoperatively. CONCLUSION: To the best of our knowledge this is the first time a study systematically and comprehensively approaches and reports KTP complications. KTP with third GP provides better results and fewer complications than previous ones. It is a modern, minimally invasive technique that helps solve several functional ocular problems and improves cosmetic appearance of the patients. Dermatological pigments should not be used as they lead to complications; instead pigments specifically tested for the eye in terms of toxicity and teratogenicity should be used.

Laser-Assisted in Situ Keratomileusis with Optimized, Fast-Repetition, and Cyclotorsion Control Excimer Laser to Treat Hyperopic Astigmatism with High Cylinder.

PURPOSE: To evaluate the visual outcomes after femtosecond laser-assisted laser in situ keratomileusis (LASIK) surgery to correct primary compound hyperopic astigmatism with high cylinder using a fast repetition rate excimer laser platform with optimized aspheric profiles and cyclotorsion control. METHODS: Eyes with primary simple or compound hyperopic astigmatism and a cylinder power ≥3.00 D had uneventful femtosecond laser-assisted LASIK with a fast repetition rate excimer laser ablation, aspheric profiles, and cyclotorsion control. Visual, refractive, and aberrometric results were evaluated at the 3- and 6-month follow-up. The astigmatic outcome was evaluated using the Alpins method and ASSORT software. RESULTS: This study enrolled 80 eyes at 3 months and 50 eyes at 6 months. The significant reduction in refractive sphere and cylinder 3 and 6 months postoperatively (p<0.01) was associated with an improved uncorrected distance visual acuity (p<0.01). A total of 23.75% required retreatment 3 months after surgery. Efficacy and safety indices at 6 months were 0.90 and 1.00, respectively. At 6 months, 80% of eyes had an SE within ±0.50 D and 96% within ±1.00 D. No significant differences were detected between the third and the sixth postoperative months in refractive parameters. A significant increase in the spherical aberration was detected, but not in coma. The correction index was 0.94 at 3 months. CONCLUSIONS: Laser in situ keratomileusis for primary compound hyperopic astigmatism with high cylinder (>3.00 D) using the latest excimer platforms with cyclotorsion control, fast repetition rate, and optimized aspheric profiles is safe, moderately effective, and predictable.

Superficial Automated Keratopigmentation for Iris and Pupil Simulation Using Micronized Mineral Pigments and a New Puncturing Device: Experimental Study.

PURPOSE: To study the outcomes and tolerance of micronized mineral pigments for corneal tattooing, using a superficial automated keratopigmentation (SAK) technique in an experimental animal model and a new puncture device to inject the pigments into the corneal stroma. METHODS: Forty eyes of 40 New Zealand rabbits were included in this study. The animals were divided into groups A and B. Both groups underwent SAK using a new automated keratopigmentation device. Micronized mineral pigments were injected through the epithelium into the corneal stroma to replicate the iris color in 25 eyes (group A), and black color was used to replicate the pupil in 15 eyes (group B). Slit-lamp examination was performed to evaluate the outcome. Histopathological examination was also performed to ascertain the presence of pigment dispersion, inflammation, and/or neovascularization. RESULTS: All 40 eyes showed good cosmetic appearance after keratopigmentation. No intraoperative complications were detected. At the first week, mild or moderated conjunctival injection was observed in 13 eyes and transitory corneal epithelial defects were also detected in 27 eyes. Examination was unremarkable 2, 4, and 6 months after surgery. No neovascularization was detected in any case in the histopathology study. CONCLUSIONS: SAK using a new automated puncture device and micronized mineral pigments achieved good cosmetic outcomes for iris and pupil simulation. This method could be a valid alternative to treat serious cosmetic eye problems that affect the superficial cornea or functional problems, such as photophobia or diplopia secondary to iris defects or trauma.

Tolerance of Micronized Mineral Pigments for Intrastromal Keratopigmentation: A Histopathology and Immunopathology Experimental Study.

PURPOSE: To study the tolerance and biocompatibility of mineral pigments for corneal pigmentation histopathologically and immunologically in an experimental animal model. METHODS: Manual intralamellar keratopigmentation was performed in 28 New Zealand white rabbits using micronized mineral pigments. Histopathological examination was performed 3 months after the surgery to determine the level of pigment diffusion, the level of inflammation, and the presence/absence of neovascularization. An immunological analysis was also performed. RESULTS: No pigment diffusion or changes in color, inflammation, or neovascularization were detected in the treated eyes. Histopathological examination corroborated clinical results regarding inflammation. Pigmented corneas showed a good cosmetic appearance without signs of ocular toxicity. From the immunological perspective, the pigments do not generate an inflammatory response in the rabbit cornea or in vitro. CONCLUSIONS: Micronized mineral pigments could be a valid alternative treatment for corneal pigmentation. Manual intralamellar keratopigmentation technique presented good cosmetic appearance without adverse effects in the treated eyes.

Corneal tolerance to micronised mineral pigments for keratopigmentation.

PURPOSE: To study the tolerance and biocompatibility of micronised mineral pigments for corneal cosmetic pigmentation in an experimental animal model. METHODS: Corneal intralamellar keratopigmentation was performed in 28 New Zealand white rabbits using micronised mineral pigments. Prophylactic actions using intraoperative antibiotic prophylaxis and gamma radiation of the pigment mixtures were performed to avoid infection. Animals were examined regularly by slit lamp to detect any sign of inflammation, pigment diffusion, colour changes or neovascularisation. Histopathological examination was performed to determine the level of pigment diffusion, the level of inflammation and the presence of neovascularisation. RESULTS: No pigment diffusion or changes in colour, inflammation or neovascularisation were detected in the eyes treated. Histopathological examination corroborated clinical results regarding inflammation. Pigmented corneas showed a good cosmetic appearance without signs of ocular toxicity. CONCLUSIONS: Micronised mineral pigments could be a valid alternative treatment for cosmetic keratopigmentation. The intralamellar keratopigmentation technique presented good cosmetic appearance without adverse effects in the eyes treated.