Pre-operative versus post-operative intravitreal aflibercept injection for management of DME in patients undergoing cataract surgery.

AIM: The aim of this paper is to investigate the need of deferring cataract surgery until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF). METHODS: A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three preoperative intravitreal (IVI) aflibercept injections with a monthly interval; the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. The primary outcome measure was the change in central macular thickness (CMT) at 1st and 6th month post-operative. The secondary outcome measures were best corrected visual acuity (BCVA) at same points and any documented adverse effects. RESULTS: Forty patients were enrolled in the study, 20 patients in each group. Means of CMT at 1 month post-operatively were significantly higher in group B than group A but no statistical difference at 6 months. There was no statistical difference between the 2 groups regarding BCVA at 1 or 6 months post-operatively. Compared with the baseline values, BCVA and CMT improved significantly after 1 and 6 months within both groups. CONCLUSION: IVI of aflibercept given before cataract surgeries does not seem to have superior effect over postoperative injections in either macular thickness or visual outcomes. Hence, preoperative controlling of DME might not be mandatory in patients undergoing cataract surgery. CLINICAL TRIAL REGISTRATION: The study is registered in clinical trial. Gov (NCT05731089).

Thyroid gland dysfunction and vitamin D receptor gene polymorphism in keratoconus.

OBJECTIVES: To detect the serum level of thyroid hormones, vitamin D and vitamin D receptors (VDR) polymorphism in keratoconus (KC) patients and to identify the association between vitamin D deficiency and thyroid dysfunction in KC. METHODS: This cross sectional study included 177 KC patients with no thyroid disorders compared to 85 healthy controls with normal corneal tomography. Measurements of thyroid stimulating hormone (TSH), free triiodothyronine (FT3), free tetraiodothyronine (FT4) and serum 25-OH vitamin D were done using Enzyme linked immusoassay (ELISA test). VDR polymorphisms were tested including [Taq I (rs731236), Apa I (rs7975232) and Bsm I (rs1544410)] using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). RESULTS: An increase in frequency of thyroid disorders (P = 0.04), decrease in serum 25(OH) vitamin D level (P < 0.001), Taq 1 and tt genotype (P < 0.001) were significantly distributed in KC patients. A significantly higher serum 25(OH) vitamin D level was reported in TT genotype, while insufficient level was more common in Tt genotype (P < 0.001). A deficient serum 25(OH) vitamin D level was predominant in tt genotype (P < 0.001). A 95% confidence interval was in TSH (1.603, 2.946), FT4 (24.145, 77.06), hypothyroidism (1.062, 67.63), insufficient (2.936, 11.643) and deficient vitamin D (5.283, 28.704) and all were significant risk factors for KC with (P < 0.05). CONCLUSIONS: Both thyroid disorders and low vitamin D are potential factors for KC development. Studying VDR at the molecular level provides interesting avenues for future research toward the identification of new KC cases.

Aflibercept with adjuvant micropulsed yellow laser versus aflibercept monotherapy in diabetic macular edema.

PURPOSE: To assess the impact of micropulsed laser (MPL) on modifying the number of aflibercept injections when used as an adjuvant therapy in diabetic macular edema (DME). METHODS: A prospective randomized interventional clinical study included patients with DME attending Al Hadi Clinic, Kuwait, during the period from May 2017 to December 2018. Patients were allocated in two groups; group A received aflibercept injections alone and group B received combined aflibercept injections followed by MPL within a week. The primary outcome was the number of Aflibercept injections in each group guided by the change in central macular thickness (CMT). All the patients were followed for 18 months. Secondary outcome measures included best corrected visual acuity (BCVA), contrast sensitivity (CS), and any recorded complications. RESULTS: Fifty-four eyes of 51 patients were included (27 in each group). There was no statistically significant difference between the two groups in baseline characteristics except for the age that was statistically higher in group B (p = 0.001). The number of injections were significantly lower in group B (4.1 ± 1.1) than group A (7.3 ± 1.1) (p < 0.005). At 18th month, there was significant reduction in CMT in both groups (p < 0.005) with no statistical difference between the two groups (p = 0.989). Final BCVA in both groups showed statistically significant improvement (p < 0.005) without statistically significant difference between the two groups (p = 0.082). In both groups, the CS showed significant improvement from baseline (p < 0.005). No ocular or systemic adverse effects were observed in either group. CONCLUSION: Supplemental MPL in eyes with DME may decrease the burden of the aflibercept injection frequency while resulting in comparable anatomical and visual outcomes.

Safety and efficacy of ultrasound ciliary plasty as a primary intervention in glaucoma patients.

AIM: To evaluate the safety and the efficacy of the ultrasound ciliary plasty (UCP) on the intraocular pressure (IOP) control in glaucomatous eyes without previous glaucoma surgery. METHODS: A retrospective study included patients with primary and secondary glaucoma who underwent UCP in Dar AlShifa Hospital, Kuwait between January 2017 to June 2018. High-intensity focused ultrasound procedures were performed under peribulbar anesthesia using the 2nd generation probe with 8s duration of each of the 6 shots. Complete ophthalmologic examinations were scheduled pre-treatment, and at 1d, 1wk, 1, 3, 6 and 12mo post-treatment. Primary outcomes were the IOP reduction and success rates at 12mo, while the secondary outcomes were the occurrence of vision threatening complications and visual acuity. RESULTS: The records of 62 eyes of 62 patients were analyzed with mean age of 63.8y (67.7% males). There was statistically significant reduction in the mean IOP from 35.2±8.3 mm Hg before treatment to 20.6±8.7 mm Hg at 12th month (P<0.0005) with a mean percentage IOP reduction of 42.3% with significant reduction in the mean number of antiglaucomatous drugs from 3.2±0.4 before treatment to 2.1±1.02 at 12mo (P<0.0005). Qualified success was achieved in 77.4% of eyes at 12mo. No major intra- or post-treatment complications were reported. CONCLUSION: Second-generation UCP prove to be effective in reducing IOP in naive glaucoma patients with lower success rates in cases of neovascular and uveitic glaucomas.

Optimization of nutraceutical coenzyme Q10 nanoemulsion with improved skin permeability and anti-wrinkle efficiency.

Coenzyme Q10 (CoQ10) is an insoluble, poorly permeable antioxidant with great biological value which acts as anti-aging and anti-wrinkle agent. To improve its permeability through topical application, the current study aimed at formulating oil/water (o/w) nanoemulsion (NE) as an efficient vehicle for delivering (CoQ10) through the skin barriers. The solubility of (CoQ10) was tested for various oils, surfactants (S), and co-surfactants (CoS). The NE region was determined by constructing pseudoternary phase diagrams. NE formulae containing 1, 2, and 3% w/w drug have been subjected to thermodynamic stability test. The formulae that passed thermodynamic stability tests were characterized by physical properties as pH, viscosity, refractive index, droplet size, zeta-potential, TEM, electroconductivity, in vitro release, and ex vivo permeation. The formula 'F2' containing 10% w/w isopropyl myristate (oil phase), 60% w/w of Tween 80: Transcutol HP mixture (S/CoSmix) at ratio 2:1, 30% w/w water and 2% w/w drug was evaluated for its anti-wrinkle efficiency using an animal model. The 'F2' formula showed 11.76 ± 1.1 nm droplet size, 1.4260 ± 0.0016 refractive index, 0.228 PDI, -14.7 ± 1.23 mv zeta potential, 7.06 ± 0.051 pH, 199.05 ± 0.35 cp viscosity, and the highest percentage of drug release in the selected dissolution media. About 47.21% of the drug was released in phosphate buffer 7.4 containing 5% w/v Labrasol and 5% w/v isopropyl alcohol through 24 h. It also showed the highest drug flux (Jss = 3.164 µg/cm2/h), enhancement ratio (Er = 8.32), and permeability coefficient (Kp = 22.14 × 10-4 cm2/h). CoQ10 NE reduced the skin wrinkles and gave the skin smooth appearance. Our investigation suggests the potential use of NE as a vehicle for enhancing solubility and permeability of CoQ10 and thus improving its anti-wrinkle efficiency.

Visumax femtolasik versus Moria M2 microkeratome in mild to moderate myopia: efficacy, safety, predictability, aberrometric changes and flap thickness predictability.

INTRODUCTION: This is an interventional prospective clinical study which was conducted to evaluate the efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate myopia. METHODS: This study included 60 eyes who were divided into two groups. Thirty eyes in group (I) in which the flap was created with Visumax FSL, while in group II (30 eyes) the Moria M2 MK was used. Keratometric, refractive, and aberrometric measurements were compared preoperatively and 3 months postoperatively. The intraoperative subtraction pachymetry (the SP 100 Handy pachymeter (Tomey, Nagoya, Japan) was used for preoperative pachymetry and flap thickness measurement. RESULTS: No significant difference was found between the two groups in regards to postoperative manifest sphere, spherical equivalent, astigmatism, safety indices nor ocular aberrations. Twenty six eyes (86.6%) in group I and 23 eyes in group II (76.6%) were within ±0.5D of the intended correction and 23 eyes (76.6%) in group I and 15 eyes in group II (50%) were within ±0.25D of the intended correction. In group I, the mean postoperative actual flap thickness was 100.12 ± 16.1 µm (81 to 122 µm), while in group II, it was 104.6 ± 20.1 µm (62 to 155 µm). The difference was statistically significant (p = 0.001). CONCLUSIONS: Both Visumax and Moria M2 MK are safe and effective in treating myopia with no statistically significant difference in induction of ocular aberrations but with potential advantage for Visumax regarding predictability. More accurate flap thickness is achieved with Visumax femtolasik. TRIAL REGISTRATION: This study was retrospectively registered on 19/6/2017. Trial registration number NCT03193411 , clinicalTrials.gov .

Ghrelin Levels in Patients With Primary Open-Angle Glaucoma.

PURPOSE: This study was aimed to assess the levels of ghrelin in aqueous humor and plasma of human eyes with primary open-angle glaucoma (POAG) and to correlate their concentrations with the severity of glaucoma. DESIGN: This was a case-control, prospective study. METHODS: Fifty patients with POAG and 35 patients with senile nonpathologic cataract (control group) were enrolled in the study prospectively. Aqueous humor samples were obtained by paracentesis from patients with glaucoma and cataract who underwent elective surgery. Aqueous humor and corresponding plasma samples were analyzed for ghrelin concentrations by radioimmunoassay diagnostic kits assay. RESULTS: Ghrelin levels were significantly lower in aqueous humor of patients with POAG with respect to the comparative group of patients with cataract (P < 0.001). There was no significant difference in the levels of ghrelin in the plasma of patients with POAG and that of patients with cataract. A positive correlation was found between plasma/aqueous humor ghrelin concentration in patients with POAG versus the control group (P < 0.001). No significant correlation was found between the levels of ghrelin and the severity of visual field loss. CONCLUSIONS: Lower levels of aqueous humor ghrelin may be associated with POAG and may be a consequence of glaucomatous damage.