Trends in presbyopia IOLs

The overall level of presbyopic and toric IOL implantation continues to increase in Europe and now accounts for 9% of current cataract procedures. The cost of the procedures remains the leading factor limiting the use of these options. These were among the main findings of the 2021 ESCRS Clinical Trends Survey conducted during the 39th ESCRS Annual Congress in Amsterdam.

Thomas Kohnen MD, PhD, FEBO, Department of Ophthalmology, University Frankfurt, Germany, reviewed the survey findings during the ESCRS Presbyopia IOLs Forum.

Since 2016, there has been an 8% increase in cataract procedures involving toric IOLs. If cost were not an issue, 38% of cataract patients with clinically significant astigmatism would receive a toric IOL, he reported.

In the 2016 ESCRS Clinical Trends survey, 7% of respondents reported implanting presbyopia-correcting IOLs, with the same percentage implanting toric IOLs. By 2021, the number implanting presbyopia-correcting IOLs and toric IOLs had grown to 11% and 15%, respectively.

The current survey showed interesting changes since 2019, when trifocals accounted for 62% of presbyopia IOLs, extended depth of focus IOls 20%, and bifocals 15%. Two years later, trifocals dropped slightly to 53%, extended depth of focus IOLs grew to 28%, and enhanced monofocals took up 11% of the pie.

When asked their reasons for any reluctance to perform more presbyopia-correcting IOL procedures, survey respondents cited costs to the patient and concerns over contrast visual acuity and nighttime quality of vision.

The survey included 154 questions, with 1,574 delegates responding. Sixty-two percent were male. There was a wide variety of practice experience, ranging from “still in training” to “more than 30 years”. Some 53% of respondents had less than ten years of experience, with 14% still in medical school or training.

The 2021 survey showed no consensus on the preferred method for treating astigmatism of 1.25 D or less, but toric IOLs were the clear favourite for 1.75 D or more of astigmatism.

The 8th ESCRS Clinical Trends Survey will be conducted in autumn 2022 at the ESCRS Annual Congress in Milan.

For more information, please visit the ESCRS Education Forum, forum.escrs.org.

Long-term study underscores merits of cross-linking in younger patients

Corneal collagen cross-linking (CXL) appears to halt the progression of keratoconus in paediatric patients, resulting in the stabilisation of visual acuity and topographic parameters over the long term, according to the results of a study presented at the ESCRS Virtual Winter Meeting 2022.

“Our results are in line with the published international series for paediatric keratoconus, showing overall good results but with a higher risk of progression than adult patients. Alternative protocols also seem to be equally effective as standard-CXL in stopping progression in these younger patients,” said Raquel Félix MD.

Dr Félix’s retrospective study reviewed the data of 44 eyes of 33 patients with progressive keratoconus under the age of 18 who underwent CXL between 2010 and 2021 at two centres in Coimbra, Portugal. Different modalities of CXL were used, including standard CXL, accelerated CXL, combined CXL, partial topography-guided photorefractive keratectomy (PRK), and customised CXL. Evaluation included best spectacle-corrected visual acuity (BSCVA), manifest refraction, and Scheimpflug tomography evaluation.

Analysing the results, Dr Félix noted keratometric and visual acuity values remained stable after CXL and reported the progression rate of 9.1% was slightly better than other paediatric CXL studies, which tend to be in the range of 20% to 24%.

“We found that efficacy in the stabilisation of paediatric keratoconus seems similar between different protocols—although combined PRK and CXL and customised CXL resulted in a better improvement in best-spectacle corrected visual acuity,” she concluded.

High-oxygen epi-on protocol shows promise for CXL treatments

A novel high-oxygen epithelium-on (epi-on) treatment protocol may be a promising alternative to epi-off protocol in room air for customised cross-linking in keratoconus patients, according to preliminary data from an ongoing study presented by Anders Behndig MD at the ESCRS Virtual Winter Meeting 2022.

“So far, our results indicate the novel high-oxygen epi-on treatment protocol may offer certain advantages compared to epi-off customised cross-linking. We hope to be able to confirm the data when the final results are available in the near future,” Dr Behndig said.

Dr Behndig’s study compared the efficacy, safety, and healing phase of two different customised remodelled vision (CuRV) cross-linking protocols in 45 patients treated bilaterally for keratoconus: one eye with epi-on CuRV with high oxygen and one eye with epi-off CuRV in room air.

The treatment protocol used HPMC-Riboflavin application for 10 minutes followed by individualised treatment patterns with a maximum effect of 7.2 to 15 j/cm², with energy distribution determined by the maximum keratometry reading (Kmax). The treatment time consistently remained 16 minutes and 40 seconds.

In terms of results, Dr Behndig said there was significantly less pain from eight hours after treatment in the epi-on eyes. Corrected and uncorrected distance visual acuity improved at key follow-up intervals up to 12 months for both groups, with no differences between the treated eyes.

However, low contrast visual acuity improved faster with the epi-on protocol, with improvement at one month for epi-on and at six months for epi-off eyes. There were no significant differences between the groups at six and 12 months. The safety data showed an improvement in corrected visual acuity, with no adverse events and no change in endothelial cell counts, he concluded.

No change in higher-order aberrations after Descemet stripping only surgery

A novel technique that uses Descemet stripping only (DSO) for patients with Fuchs’ endothelial dystrophy showed no relevant changes in terms of lower or higher-order aberrations six months after treatment, according to a study presented at the ESCRS Virtual Winter Meeting 2022.

“We did not have any significant changes concerning the refraction from pre-DSO treatment to post-DSO treatment. We did have reduced higher-order aberrations (HOAs) for the posterior surface of the cornea, but we did not really have relevant changes concerning the total cornea because some HOAs increased and some decreased,” said Nino Hirnschall MD, PhD.

DSO involves creating a small (4–5 mm) descemetorhexis to remove the diseased endothelium and guttae without any donor graft placement, Dr Hirnschall explained. It is currently used in conjunction with a topical Rho-associated kinase (ROCK) inhibitor such as ripasudil to increase cell density and hasten corneal clearance.

“However, we still have about 20% of patients who do not have corneal clearance at all after DSO, so these have to undergo Descemet Membrane Endothelial Keratoplasty (DMEK) afterwards,” he said.

As DSO alters the posterior surface of the cornea, Dr Hirnschall said it was important to determine if the surgery was inducing or reducing higher-order aberrations.

The study included 25 eyes of 25 patients, with three patients excluded because of insufficient corneal clearance. The team waited six months after surgery to obtain final measurements to allow sufficient time for the honeycomb oedema often seen in DSO with ROCK inhibitors to resolve.

“We did not really have any significant change in subjective refraction, just a very mild hyperopic shift of +0.09 D,” Dr Hirnschall concluded.

Study highlights benefits of transepithelial PRK

Myopic patients treated with transepithelial photorefractive keratectomy (tPRK) obtained better uncorrected visual acuity outcomes and experienced less pain and haze than those treated with conventional PRK, according to a poster study presented at the ESCRS Virtual Winter Meeting 2022.

“The results of our study showed the superiority of the tPRK method over standard PRK in some parameters when correcting moderate myopia,” reported Nader Nassiri MD, Vanak Ophthalmology Clinic, Tehran, Iran.

Dr Nassiri’s clinical study included 120 eyes from 60 consecutive patients with moderate myopia who were randomly assigned to be operated using either tPRK or traditional PRK method. In tPRK, ablation of the corneal epithelium and stroma is performed using an excimer laser rather than mechanical or chemical debridement techniques.

The improvement in patientsʹ uncorrected and best-corrected visual acuity was statistically significant at one and three months after surgery for both groups. The mean UCVA improvement was significantly higher in the tPRK group, but this difference was not statistically significant regarding the BCVA improvement. The mean spherical equivalent change in the PRK group after one-month follow-up was 3.68 (+1.00) and 4.12 (+0.92) in the tPRK group, indicating a better improvement in the tPRK group.

The mean haze in patients undergoing tPRK was significantly lower than the PRK group one month postoperatively. Patients undergoing tPRK also experienced significantly less pain and discomfort compared to the PRK group. There was no difference between the two groups regarding intraocular pressure after surgery.

Therapeutic contact lens holds promise in treating bacterial keratitis

A novel therapeutic contact lens that increases the overall contact time of antimicrobial drug in the eye may speed up corneal healing in cases of infectious keratitis, help address issues of compliance, and reduce treatment burden for patients, according to a study presented at the ESCRS Virtual Winter Meeting 2022.

“The concept of using a novel drug repository contact lens is effective in prolonging corneal antimicrobial availability and drug contact time over the lesion and has demonstrated in this study that corneal healing hastens, which may affect the overall outcomes in bacterial keratitis,” said Lional Daniel Raj Ponniah MD.

The proprietary contact lens is designed with dual base curves, resulting in a central reservoir and fenestrations to enable the capture of topical antimicrobial.

Dr Ponniah’s randomised controlled study compared the efficacy of the therapeutic contact lens with conventional topical antibiotic treatment in 40 patients with bacterial keratitis, using moxifloxacin 0.5% as the microbial of choice in both groups. Ulcer size and depth, anterior chamber reactions, corneal haze, and pain were evaluated at 12 hours and days 1, 3, 5, and 14.

The results showed pain relief and resolution of the bacterial keratitis was faster in patients treated by contact lens. Anterior chamber reaction also resolved faster within three days in CL-treated patients.

Summing up, Dr Ponniah said that using a drug repository contact lens may reduce the regimen of antibiotics, decrease treatment burden on the medical staff, improve patient tolerance, and reduce toxicities, effectively bypassing the loading dose concept.

Early intervention improves outcomes in fungal keratitis

Eyes with yeast fungal keratitis were shown to have better clinical outcomes than eyes with filamentary keratitis in a large-scale retrospective study carried out over 15 years at a Portuguese centre.

“Our study also showed commencement of antifungal therapy within 72 hours of clinical onset was associated with greater visual acuity improvement,” said Rosa Pinheiro MD at the ESCRS Virtual Winter Meeting 2022.

Dr Pinheiro’s retrospective comparison study set out to compare risk factors, clinical features, and management outcomes of culture-proven filamentous and yeast fungal keratitis. The team identified all cases of fungal keratitis from the microbiologic records between 2005 and 2020 at Coimbra University Hospital in Portugal. Demographic data, risk factors, logMAR visual acuity (VA), therapeutic management, and functional outcomes were all noted.

Of the 49 eyes of 49 patients identified with fungal keratitis, 33 had a filamentous fungus (group 1) and 16 had a yeast fungus (group 2). Patients with filamentous fungi had significantly better visual acuity at presentation and eyes with yeast fungi had a greater visual acuity improvement following treatment.

The most prevalent risk factors overall were systemic diseases (62%), previous ocular surgery (41%), and, in particular, penetrating keratoplasty (34%).

“These are all well-known predisposing factors to fungal keratitis. Penetrating keratoplasty was performed in 43% of our patients and is considered an effective treatment for fungal keratitis that does not respond to antifungal medication,” Dr Pinheiro said.

No correlations were found between filamentous and yeast fungi and contact lens use, history of trauma or surgery, corneal perforation, and previous penetrating keratoplasty. Initiation of antifungal therapy within 72 hours of clinical onset was associated with a greater visual acuity improvement.

Microbiological profile of infectious keratitis unchanged during COVID-19 pandemic

The long-term use of face masks does not seem to promote significant changes in the microbiological causes of infectious keratitis, according to a study presented at the ESCRS Virtual Winter Meeting 2022.

“Most of the microorganisms identified in our study are known commensals of the upper respiratory tract or pathogenic agents associated with respiratory infections. However, our results did not significatively differ from the ones previously published in 2019 regarding the microbiological profile of infectious keratitis in our tertiary centre in Porto, Portugal, from 2009 to 2018,” said Mário Lima Fontes MD.

Discussing the background to the study, Dr Fontes noted the COVID-19 pandemic introduced profound changes in daily habits, including the frequent use of face masks.

“Numerous reports from around the world pointed to an increase in dry eye symptoms, due to an upwards route of the exhaled air over the ocular surface. Therefore, we speculated if this mechanism could have led to a change in the microbiological profile of infectious keratitis,” he said.

Dr Fontes carried out a retrospective study based on a survey review of electronic medical records of all patients with presumed infectious keratitis between March 2020, when the first cases of COVID-19 were identified in Portugal, and October 2021.

A total of 194 samples from the same number of patients were included, with a 43% culture-positive rate. Bacteria accounted for 83% of all positive scrapes (61% were gram positive and 35% were gram negative), fungi for 12%, and acanthamoeba for 4%. The most frequent agent identified was corynebacterium macginleyi (23%), followed by staphylococcus aureus and pseudomonas aeruginosa (17% each) and streptococcus pneumoniae (8%).

The most common ophthalmologic risk factors identified were the use of contact lenses (41%), previous ocular trauma (9%), and history of corneal ulcer (8%). Diabetes (8%) and poor systemic status/multiple comorbidities (5%) were the most frequent systemic associations.

Topical azithromycin for ocular surface disease may reduce systemic side effects

Topical application of azithromycin may provide an acceptable alternative to systemic doxycycline in patients with meibomian gland dysfunction (MGD), according to the results of a study presented at the ESCRS Virtual Winter Meeting 2022.

“Our study showed that systemic side effects were less common with azithromycin compared to systemic doxycycline without losing any efficacy in terms of improving the signs and symptoms of ocular surface disease (OSD) in patients with MGD,” said Andreas Schlatter MD.

MGD is a major cause of ocular surface disease, with treatment strategies including but not limited to lid hygiene for mild cases and anti-inflammatory treatment for more severe cases, Dr Schlatter said. Although both topical azithromycin and systemic doxycycline have been found effective in MGD, the effect of both therapies on tear film thickness (TFT) remains unclear.

In the study, 23 patients with MGD were randomised to either receive 15 mg/g topical azithromycin twice daily in both eyes for two days, then once daily for 26 days, or 100 mg oral doxycycline twice daily for six weeks. In total, four study visits at intervals of two weeks were scheduled.

The main outcome of the study was change in TFT as measured with ultra-high resolution optical coherence tomography (UHR-OCT). Ocular Surface Disease Index (OSDI), OSD composite sign score, lipid layer thickness (LLT), tear film osmolarity, conjunctival staining (as assessed with Lissamine green), and Schirmer Test I served as secondary outcomes.

In terms of results, TFT significantly increased in both groups, with no difference between the two. Additionally, OSDI score and OSD composite signs significantly decreased in both groups. There were no significant changes in LLT, tear film osmolarity, conjunctival staining, or Schirmer Test I. Systemic adverse events (AEs) were more frequent in the doxycycline group, while in the azithromycin group, mainly local AEs occurred (burning eyes).

Case study highlights ulcerative keratitis triggered by COVID-19

The intriguing case of a patient whose peripheral ulcerative keratitis (PUK) was in all likelihood triggered by a COVID-19 infection was the subject of a poster study at the ESCRS Virtual Winter Meeting 2022.

“With no previous ocular history and in the absence of any confirmed associations/causes from the extensive investigations performed, we believe the peripheral ulcerative keratitis (PUK) was triggered by COVID-19 infection. Our case highlights another possible ocular manifestation of COVID-19 [that] ophthalmologists should be aware of,” reported Mrinal Rana MD.

The case under investigation was of a 52-year-old female who presented to eye casualty with a sectoral nasal redness and a painful, photophobic left eye with a two-month history of a persistent nodular episcleritis that developed one week after she tested positive for COVID-19.

The patient had no previous ophthalmic history or episodes of ocular inflammation, and her systemic history was normal. Her episcleritis responded to topical eyedrops but developed recurrence with worsening of signs and a mid­stromal crystalline keratopathy—at which point, she was referred to the corneal unit. Topical steroid treatment given over a longer tapering period of six weeks caused temporary resolution, but the patient returned a few weeks later with signs of peripheral ulcerative keratitis, early corneal thinning, and worsened corneal keratopathy with stromal oedema and increased intraocular pressure.

Multiple investigations, including corneal scrapes, swabs, and blood tests to look for all possible associated causes of PUK, all returned negative. After an initial poor response to intensive topical therapy with fluoroquinolone monotherapy, the patient was given a daily low dose of oral prednisolone and twice-daily topical dexamethasone drops that controlled the infection.

The study authors concluded COVID-19 infection leading to immune dysregulation and a pro-inflammatory state of the ocular surface probably resulted in the manifestations described.

LASIK and accelerated CXL appears safe in myopic diabetic patients

LASIK combined with accelerated corneal cross-linking (CXL) seems to offer a safe and effective treatment modality in diabetic myopic patients, according to the results of a study presented at the Cornea Day session as part of the ESCRS Virtual Winter Meeting 2022.

“Although a longer follow-up is needed to confirm these results, our study indicates LASIK in combination with CXL is safe on the corneal endothelium of diabetic myopic patients,” said Mohamed Mahmoud MD.

Dr Mahmoud’s prospective comparative interventional case series included 120 eyes of 60 myopic patients treated with LASIK combined with accelerated CXL. Patients were divided into two groups: group A contained 60 eyes of diabetic patients, while group B contained 60 eyes of non-diabetic patients. Corneal endothelium was evaluated by specular microscope preoperatively and after three and six months postoperatively.

Dr Mahmoud noted the endothelial cells density (ECD) showed statistically significant changes after three and six months postoperatively in group A while group B showed statistically significant changes after three months without significant change after six months. Furthermore, both groups improved close to preoperative density levels, with no significant differences between them, at the end of six months follow-up.

Corneal endothelial cell morphology—as determined by polymegathism and pleomorphism values—showed a statistically significant difference in diabetic patients after six months, with no significant change evident in the non-diabetic patients.

Summing up, Dr Mahmoud said LASIK with accelerated CXL seemed safe and effective for diabetic patients with myopia, but further studies with longer follow-up are required to confirm his group’s findings.

Novel customised PRK technique for myopia shows promise

A new minimally invasive customised myopic PRK technique delivers rapid visual rehabilitation and a more comfortable postoperative recovery when compared to traditional PRK and may offer an attractive alternative to either LASIK or SMILE for myopic corrections in appropriate patients, according to A John Kanellopoulos MD.

“This novel PRK technique may minimise pain and visual debilitation by accelerating re-epithelialization and early visual recovery. By using this approach, we make patients very happy because this is a very seamless procedure similar to LASIK or SMILE. It gives us another option for patients with thin corneas, as not every eye is made for a lamellar refractive procedure,” Dr Kanellopoulos said at the Cornea Day session as part of the ESCRS Virtual Winter Meeting 2022.

Dr Kanellopoulos’ prospective case series included 104 eyes of 52 patients who underwent PRK for bilateral myopia or myopic astigmatism. Epithelial removal was performed using the Epi Clear™ epikeratome (ORCA Surgical) using customised shape and diameter to denude a 6.5 mm to 7.0 mm disk from the central cornea. A non-steroidal anti-inflammatory drug (Bromfenac 0.9 mg/mL) was used on the first postoperative day. Visual acuity, corrected and uncorrected distance visual acuity (CDVA, UDVA) refraction, postoperative pain measured on a subjective scale, epithelial healing, and epithelial mapping profile were evaluated for 12 months.

The results showed minimal postoperative pain and discomfort for the majority of patients. All eyes were epithelialized by day four, and all eyes attained 20/25 immediately after the procedure and out to day four.

Dr Kanellopoulos concluded by saying this minimally invasive PRK approach offers clear advantages over traditional PRK and could provide a viable alternative to either SMILE or LASIK for select cases.

Positive outcomes with blended vision for presbyopia correction

Using laser vision correction to create customised blended vision may offer surgeons a safe and effective treatment option for presbyopic patients in the absence of cataract, according to the results of a study presented at the Cornea Day session as part of the ESCRS Virtual Winter Meeting 2022.

“We believe that this approach, called PresbyEDOF, is an interesting alternative procedure of suitable excimer laser presbyopia correction. Using a method safer than wearing contact lenses, we were able to improve quality of life for every patient,” said Detlev Breyer MD.

Explaining the background to the study, Dr Breyer noted there are currently two laser platforms on the market designed to achieve a depth of focus effect on the cornea: PRESBYOND® (Carl Zeiss Meditec) and PresbyMAX® (SCHWIND).

“We have over 10-years’ experience with PRESBYOND laser surgery inducing positive spherical aberrations to achieve an EDOF effect with the addition of 1.5 D and inducing an anisometropia of -1.5 D,” he said.

Although the PresbyMAX laser routinely offers an anisometropia of -0.89 D and 1.25 D negative spherical aberration, Dr Breyer said this was insufficient to deliver true spectacle independence for his patients.

“We therefore increased the anisometropia using PresbyMAX to 1.5 D and an extended depth of focus effect of 1.5 D using negative spherical aberrations,” he said.

For the study, all patients answered a questionnaire concerning everyday experience, subjective optical quality, subjective optical side effects, and quality of life one to three months after surgery.

At three months, more than 85% of patients said they could read a newspaper without visual aids, more than 90% said they didn’t use glasses for various hobbies, and night driving improved significantly for a majority of patients.

Summing up, Dr Breyer said the everyday experience, subjective optical quality, subjective optical side effects, and quality of life were clinically significant raised in all patients, all of whom said they would recommend the procedure to a friend.

Off-the-shelf toric IOLs may offer economic solution for majority of patients

Using off-the-shelf toric IOL models (TIOLs) does not appear to be inferior to using a fully tailored approach for patients with up to 5.0 D of preoperative astigmatism, according to a study presented at the Cornea Day session as part of the ESCRS Virtual Winter Meeting 2022.

“The use of off-the-shelf toric lenses with additional opposite clear corneal incisions may improve visual acuity and allow patients to achieve spectacle independence for distance vision. Our preliminary data suggests it may not be inferior to using fully tailored TIOLs,” said Khayam Naderi MD.

Explaining the rationale for the study, Dr Naderi said up to 20% of patients undergoing cataract surgery in the National Health Service in the United Kingdom have preoperative astigmatism of more than 1.5 D.

“Toric IOLs are available in only a small proportion of NHS hospitals due to increased associated costs and storage issues. A reduced in-house bank of toric IOLs can reduce additional costs, allowing NHS patients routine access to them and their associated refractive benefits,” he said.

Dr Naderi’s prospective single-masked randomised case-controlled trial included 66 patients with pre-existing regular corneal astigmatism of 1.5 D or more. Thirty-two patients were randomised to the fully tailored treatment group, with 34 patients in the off-the-shelf group.

In terms of results, the visual acuity, refractive outcomes, and patient-reported outcome measures (PROMs) were comparable between both groups of patients six months after surgery.

“Thus far, we have not needed to take any patients from either group back to theatre to reposition the lens. Our preliminary results suggest using the off-the-shelf model might not be inferior to a fully tailored approach for up to 5.0 D of regular astigmatism,” Dr Naderi concluded.