Archive for month: August, 2024

A study assessed the effect of an intensive initial IOP lowering treatment strategy on the progression of visual field damage. A total of 242 patients with newly detected early or moderate untreated open-angle glaucoma were enrolled at two university hospitals in Sweden. Participants were randomly allocated (1:1) to either initial treatment with intensive IOP-lowering medications followed by 360° laser trabeculoplasty (LTP), or to traditional mono-therapy, which was increased when deemed necessary. The primary study outcome of interest was the predicted remaining visual field, as measured by the visual field index (VFI) at projected end of life. Results: The median untreated IOP was 24 mmHg in both treatment groups. During follow-up, median and mode IOP was 17 mmHg in the mono- and 14 mmHg in the multi-treated group. In the mono-treated group the median VFI at projected end of life was 79.3%, and in the multi-treated group 87.1%, p=0.15. Annual rate of progression of visual field damage was faster in mono-treated than in multi-treated participants; median losses per year were 0.65 and 0.25 percentage units respectively, p=0.09. Progression events occurred in 21% of the mono- and in 11% of the multi-treated participants, p=0.03. Adverse events, mostly mild, were reported in 25% of the mono-, and in 36% of the multi-treated participants. Differences in visual field outcomes between treatment groups were more pronounced in participants having higher baseline IOP defined by median split of untreated IOP values. In the overall analysis the visual field outcomes were not overwhelming better in the multi-treated group, but post-hoc analysis showed definite benefit in patients with higher untreated IOP. Based upon the results of this study, initial intensive treatment may be considered in glaucoma patients with high untreated IOP at diagnosis, while we found no evidence that multi-therapy should be given routinely to all glaucoma patients.

Reference:

Bengtsson B, Heijl A, Aspberg J, Jóhannesson G, Andersson-Geimer S, Lindén C. The Glaucoma Intensive Treatment Study (GITS): a randomized controlled trial comparing intensive and standard treatment on 5 years visual field development. Am J Ophthalmol. 2024 Jun 21:S0002-9394(24)00262-9. doi: 10.1016/j.ajo.2024.06.017. Epub ahead of print. PMID: 38909742.

Keywords:

Intensive, glaucoma, treatment, affect, visual, field, outcomes, patients, lower, baseline, high IOP, study, CRT, Open-angle Glaucoma, treatment intensity, visual field, IOP, Bengtsson B, Heijl A, Aspberg J, Jóhannesson G, Andersson-Geimer S, Lindén C

Freckles and lentigines are common pigmented problems which not only cause substantial cosmetic morbidity but also create psychosocial concern. The available modalities for the treatment of pigmented lesions are often unsatisfactory for patients, require a long treatment period, and often cause skin irritation. With the advent of lasers, safe and effective treatment options for epidermal pigmentation have become more varied for different Fitzpatrick skin types. We aimed to evaluate the efficacy and safety of 577-nm yellow laser in the treatment of pigmented epidermal lesions. This study was carried out on 50 patients presented with pigmented epidermal lesions presented with freckles and 25 presented with lentigines). Each patient received four treatment sessions with a 577-nm diode laser at 2-week intervals. Results: There was significant improvement in freckles and lentigines, as 23 out of 50 patients showed marked improvement, 11 patients showed moderate improvement, 10 patients showed mild improvement, and only six patients had no changes. Moreover, 23 patients were very satisfied, 18 patients were satisfied, and nine patients were not satisfied. As regards the safety of the 577-nm yellow laser, there was no significant adverse effect among patients except pain, erythema, and hyperpigmentation, which resolved within one month after treatment. This study showed that the 577-nm yellow laser is an effective, safe, and well-tolerated device in the treatment of freckles and lentigines.

Reference:

Mohamed, E.M., Abd Elaleem, H.L., Ahmed, M.A.H. and Rageh, M.A. (2024), Efficacy and Safety of 577-nm Yellow Laser in the Treatment of Pigmented Epidermal Lesions. Lasers in Surgery and Medicine, 56: 551-556. https://doi.org/10.1002/lsm.23814

Keywords:

577-nm yellow laser effective, safe, and well-tolerated, device, treatment, freckles, lentigines, finds, study, Mohamed, E.M., Abd Elaleem, H.L., Ahmed, M.A.H. and Rageh, M.A.

Despite large clinical trials and meta-analyses that show no
association between dydrogesterone and congenital anomalies, some recently
retracted publications have postulated an association with teratogenicity.
Dydrogesterone is also often rated as less safe than bioidentical progestins. A
systematic review was conducted by Katalinic et al. according to a
pre-specified protocol with searches on Medline, Embase, Cochrane Central
Register of Controlled Trials (CENTRAL), and Clinicaltrials.gov. The search was
limited to human studies, with no restrictions on language, geographical
region, or date. The search algorithm used a PICO (Population, Intervention,
Comparison, Outcome)-style approach combining both simple search terms and
medical subject heading terms. As congenital anomalies are mostly reported as
secondary outcomes, the search term ‘safety’ was added.

Interventional study and observational study (OS) designs
were eligible for inclusion. Inclusion criteria were: women >17 years old
treated for threatened miscarriage, recurrent pregnancy loss, and/or ART; the
use of dydrogesterone in the first trimester compared with placebo, no
treatment or other interventions; and reporting of congenital anomalies in
newborns or infants ≤12
months old (primary outcome). Two authors (A.K., M.R.N.) independently
extracted the following data: general study information, study population
details, intervention and comparator(s), and frequencies of congenital
anomalies (classification, time of determination, and type).

Of the 897 records retrieved during the literature search,
47 were assessed for eligibility. Nine studies were included in the final
analysis: six randomized controlled trials (RCTs) and three OSs. Among the
RCTs, three had a low risk and three a high risk of bias. Two of the OSs were
considered to have a serious risk of bias and one with critical risk of bias
and was excluded for the evidence syntheses. The eight remaining studies included
a total of 5070 participants and 2680 live births from 16 countries. In the
meta-analysis of RCTs only, the overall risk ratio (RR) was 0.92 [95% CI 0.55;
1.55] with low certainty. When the two OSs were included, the overall RR was
1.11 [95% CI 0.73; 1.68] with low certainty.

Even though this systematic review, based on RCTs, gave no
hint for an increased risk for congenital anomalies, further evidence should be
generated to enhance the body of evidence. Pharmacovigilance data could be used
as a ‘sign giver’, but the evidence level of such data is limited due to
different reasons (such as incomplete reporting, missing risk factor
adjustment, etc.). More high-quality evidence is needed. However, as randomized
controlled reproductive medicine studies rarely focus on fetal safety as a
primary endpoint, there is no evidence at the highest level available for this
topic, and there probably never will be. Authors suggest that more new
randomized controlled studies in the field of threatened miscarriage or ART
involving dydrogesterone in the first trimester of pregnancy should include
standardized assessment of congenital anomalies as a secondary outcome.
Further, it should be discussed whether information on luteal supplementation
could be added to national and systematic registries for congenital anomalies
to be able to estimate the effects of these therapies and, if necessary, their extent
on a population basis. Authors believe that the systematic review and
meta-analysis provide the best possible reassurance to both clinicians and
patients alike that dydrogesterone adds no relevant additional risk for
congenital anomalies above the rate that might be expected for all progestogens
or environmental and genetic factors.

Source: Katalinic et al.; Human Reproduction Open, 2024, 2024(1),

hoae004 https://doi.org/10.1093/hropen/hoae004