Category: Statistics

Indian J Ophthalmol. 2021 Sep;69(9):2475-2480. doi: 10.4103/ijo.IJO_165_21.

ABSTRACT

PURPOSE: To compare the efficacy and the tolerability of preservative-free Tafluprost 0.0015% (TP) vs Latanoprost 0.005% (LP) in patients with primary open-angle glaucoma (POAG).

METHODS: Prospective, randomized, crossover study included patients with early POAG attending the outpatient clinic from July 2019 to February 2020. Patients were divided into 2 groups: group A included patients receiving TP and group B receiving LP. After 2 months, treatment was stopped for 1 month (washout period) then drops were switched between the groups for further 2 months. Intraocular pressure (IOP) was recorded at baseline and monthly until 5 months. Efficacy was measured by the IOP reduction at the end of each treatment period. Tolerability was assessed both subjectively (questionnaire on ocular comfort) and objectively (ocular findings) at the end of each period.

RESULTS: A total of 30 patients were allocated into two groups (15 patients each). There was no statistically significant difference between the 2 groups in baseline clinical examinations. All the eyes in both groups achieved IOP reduction >20% compared to baseline values, with no statistically significant difference in between. Corneal erosions and conjunctival hyperemia were significantly higher in LP-treated eyes throughout the study, regardless of the sequence. Tear break-up time scores significantly worsened after LP at the 2^nd and 5^th month (P < 0.001and P = 0.026 respectively) but not after TP treatment (P = 0.719 and P = 0.164). Significant exacerbation in all patients’ symptoms was noticed on switching from TP to LP.

CONCLUSION: : Tafluprost was proved to exhibit a comparable effect on IOP control in POAG patients, as Latanoprost drops resulted in marked alleviation in both subjective and objective ocular discomfort manifestations.

PMID:34427247 | DOI:10.4103/ijo.IJO_165_21

Indian J Ophthalmol. 2021 Sep;69(9):2421-2424. doi: 10.4103/ijo.IJO_3052_20.

ABSTRACT

PURPOSE: To measure the corneal sensitivity in patients with multiple sclerosis (MS), to compare it with normal values and to study its correlation with different disease characteristics.

METHODS: Corneal sensitivity of 28 MS patients was compared to corneal sensitivity of 28 age- and gender-matched normal controls. Corneal sensitivity was measured using the Cochet-Bonnet esthesiometer and was correlated to the duration, type and severity indexes of the disease.

RESULTS: Corneal sensitivity was comparable between both groups (P = 0.79). No statistically significant correlation was found between corneal sensitivity and the duration of MS (P = 0.55) nor the severity indexes of MS (expanded disability status scale [EDSS] P = 0.52, global multiple sclerosis severity score [MSSS] P = 0.64). Following subgroup analysis, only the primary progressive (PPMS) form of MS had a reduced corneal sensitivity with P = 0.023, while remittent-recurrent (RRMS), secondary progressive (SPMS), and clinically isolated (CIS) forms of MS did not have any reduction in the corneal sensitivity. “ROC curve analysis” showed an area under the curve of 0.48.

CONCLUSION: In the exception of PPMS subtype, MS patients have similar corneal sensitivity in comparison to controls. Cochet-Bonnet esthesiometer does not seem to be a good diagnostic tool or a disease severity marker for patients with MS.

PMID:34427235 | DOI:10.4103/ijo.IJO_3052_20

Indian J Ophthalmol. 2021 Sep;69(9):2447-2451. doi: 10.4103/ijo.IJO_2314_20.

ABSTRACT

PURPOSE: The aim of this study was to compare the cost-effectiveness and perform cost-utility analysis of Descemet stripping automated endothelial keratoplasty (DSAEK) vs. penetrating keratoplasty (PK) in Indian population.

METHODS: This was an institutional, ambispective, observational study. Patients who underwent PK or DSAEK for endothelial dysfunction were included and followed up for 2 years; those with other ocular comorbidities were excluded. The analysis was performed from the patient’s perspective receiving subsidized treatment at a tertiary care hospital. Detailed history, ophthalmic examination, total expenditure by patient, and clinical outcomes were recorded. The main outcome measures were best spectacle-corrected visual acuity (BSCVA), graft survival (Kaplan-Meier survival estimates), incremental cost-effectiveness ratio (ICER), and incremental cost-utility ratio (ICUR). Utility values were based on quality-adjusted life years (QALYs) associated with visual acuity outcomes. Statistical analysis was performed using SPSS software package, version 12.1; a value of P < 0.05 was considered statistically significant.

RESULTS: A total of 120 patients (PK: 60, DSAEK: 60) were included. At 2 years, for a similar logMAR BSCVA, [PK (0.32 ± 0.02), DSAEK (0.25 ± 0.02); P = 0.078], the overall cost for PK (13511.1 ± 803.3 INR) was significantly more than DSAEK (11092.9 ± 492.1 INR) (difference = 1952.6 INR; P = 0.01). ICER of DSAEK relative to PK was -39,052 INR for improvement in 1 logMAR unit BSCVA. ICUR of DSAEK relative to PK was -1,95,260 INR for improvement in 1 QALY.

CONCLUSION: DSAEK was more cost-effective than PK in patients with endothelial dysfunction at 2 years.

PMID:34427242 | DOI:10.4103/ijo.IJO_2314_20

Indian J Ophthalmol. 2021 Sep;69(9):2401-2405. doi: 10.4103/ijo.IJO_2747_20.

ABSTRACT

PURPOSE: To identify the exact time point during after following pterygium excision with a modified technique of sutureless, glueless limbal-conjunctival autograft, when stabilization of the change in corneal curvature is achieved; correlate size of pterygium with uncorrected visual acuity and astigmatism at baseline, and assess changes in these parameters postoperatively over time.

METHODS: This prospective study longitudinally assessed 30 eyes of 30 north Indian adults with primary pterygium encroaching upon ≥1 mm of the cornea pre- and postoperatively at 1 week and then monthly for 4 months, recording uncorrected (UCVA) and best-corrected logMAR visual acuity, astigmatism and keratometry. Results were analyzed using ANOVA, Mauchly’s test of sphericity with Greenhouse-Geisser correction, and post-hoc test using Bonferroni correction. Pearson’s correlation coefficient r > 0.5 was considered clinically significant, and P < 0.05 statistically significant.

RESULTS: Pterygium size was well correlated with pre-operative astigmatism (r = 0.867, P < 0.001) and pre-operative UCVA (r = 0.856, P < 0.001). There was mean improvement of 0.43 logMAR units of visual acuity (P < 0.00001), a mean increase of 0.79D of keratometric value for the flatter meridian (P < 0.00001) and a mean reduction of 2.00D of astigmatism (P < 0.00001). At 2-month follow-up, the keratometric value for the flatter meridian approached the final keratometric reading at 4 months such that the difference was not significant (t = 1.185, P = 0.245). There were no significant complications or recurrence during the follow-up period.

CONCLUSION: Pterygium excision with modified autograft reduced corneal astigmatism and improved visual acuity comparable to classical technique. Alteration in corneal curvature stabilizes 2 months after surgery, when spectacle correction can be given to patients.

PMID:34427231 | DOI:10.4103/ijo.IJO_2747_20

Indian J Ophthalmol. 2021 Sep;69(9):2417-2420. doi: 10.4103/ijo.IJO_3434_20.

ABSTRACT

PURPOSE: To describe the clinical profile of patients with ocular Calotropis poisoning presenting to a multitier ophthalmology hospital network in India.

METHODS: This cross-sectional hospital-based study included 2,047,360 new patients presenting between August 2010 and March 2020. Patients with a clinical diagnosis of Calotropis poisoning in at least one eye were included. The data were collected using an electronic medical record system. Descriptive statistics using mean ± standard deviation and median with inter-quartile range (IQR) were used to elucidate the demographic data. Chi-square test was done for univariate analysis.

RESULTS: Overall, 362 (0.018%) new patients were diagnosed with ocular Calotropis poisoning during the study period. The mean age of the patients was 44.10 ± 18.61 years. The incidence rates were 0.013% in children and 0.018% in adults. Males were 57.46% and 87.29% had unilateral affliction. A significant number of patients presented from the rural geography (59.67%) and were from the higher socioeconomic class (72.65%). About a fourth of the patients were homemakers (23.48%) followed by agriculture workers (18.23%). Of the 408 affected eyes, 49.26% had mild visual impairment (<20/70) followed by moderate visual impairment (>20/70 to ≤ 20/200) in 23.28%. The most common clinical signs were conjunctival congestion (61.03%), descemet membrane folds (57.35%), stromal edema (30.39%), and corneal epithelial defect (24.51%).

CONCLUSION: Calotropis poisoning in individuals seeking eye care in India is very rare. It is commonly unilateral and occurs more in the rural geography. It is common in middle-aged males and may affect vision due to involvement of the cornea.

PMID:34427234 | DOI:10.4103/ijo.IJO_3434_20

Indian J Ophthalmol. 2021 Sep;69(9):2361-2366. doi: 10.4103/ijo.IJO_3539_20.

ABSTRACT

PURPOSE: The purpose of this study is to evaluate the anatomical and functional outcomes of 25-gauge (G) pars plana vitrectomy (PPV) in patients with cytomegalovirus retinitis (CMVR)-related rhegmatogenous retinal detachment (RRD).

METHODS: Single-center retrospective consecutive case series of patients who underwent 25-G PPV for CMVR-related RRD repair with a minimum follow-up of 3 months. Complete anatomic success was defined as the complete attachment of retina including the periphery. Best-corrected visual acuity (BCVA) of ≥20/400 was defined as functional success.

RESULTS: Sixteen eyes of 15 patients were included in the study. Eleven patients were human immunodeficiency virus positive, three patients had hematological malignancies, and one patient suffered from dyskeratosis congenita. The mean follow-up was 20.5 ± 17.4 months (range 3-60 months). Complete anatomical success was seen in 15 eyes (93.75%). One eye had a residual inferior detachment with attached macula. Silicone oil was used as tamponade in 15 eyes and C₃F₈ gas in one eye. The mean change in BCVA was statistically significant, preoperative LogMAR BCVA was 2.05 ± 0.94 while the final follow-up postoperative LogMAR BCVA was 1.03 ± 0.61 (P < 0.001). Thirteen eyes (81.25%) had final BCVA ≥20/400.

CONCLUSION: Microincision vitrectomy surgery can achieve excellent retinal reattachment rates in post-CMVR RRDs without significant intraoperative and postoperative complications. The visual outcome varies depending on the status of the optic disc and macula. Majority of the patients maintained functional vision.

PMID:34427223 | DOI:10.4103/ijo.IJO_3539_20

Indian J Ophthalmol. 2021 Sep;69(9):2378-2384. doi: 10.4103/ijo.IJO_2086_20.

ABSTRACT

PURPOSE: The aim of this study was to determine the alteration in ganglion cell complex and its relationship with retinal nerve fiber layer (RNFL) thickness as measured by spectral-domain optical coherence tomography (OCT) in pituitary adenoma cases and also its correlation with visual field (VF).

METHODS: This is a prospective comparative study wherein detailed neuro-ophthalmic examination including perimetry, RNFL and ganglion cell layer inner plexiform layer (GCL-IPL) thickness were measured preoperatively in the cases of pituitary adenoma with chiasmal compression with visual symptoms and field changes who were planned for neuro-surgical intervention. These parameters were repeated 1 year after the surgery. GCL-IPL, RNFL parameters were compared with controls and were correlated with VF mean deviation (MD). The diagnostic power of GCL-IPL was tested using the receiver operating characteristic (ROC) curve. Healthy age and sex-matched controls without any ocular and systemic abnormality were taken for comparison.

RESULTS: Twenty-four patients qualified the inclusion criteria. A significant thinning of GCL-IPL (P = 0.002) and RNFL (P = 0.039) was noticed in the pituitary adenoma group. GCL-IPL (r = 0.780 P < 0.001) and RNFL (r = 0.669, P < 0.001) were significantly correlated with the MD. The ROC curve values of GCL-IPL were 0.859 (95% confidence interval 0.744% to 0.973) and of RNFL were 0.731 (95% confidence interval 0.585-0.877). The diagnostic ability of GCL-IPL was more as compared to the RNFL analysis, although it was statistically insignificant (P = 0.122).

CONCLUSION: GCL-IPL measurements on the OCT are a sensitive tool to detect early anterior visual pathway changes in chiasmal compression for pituitary adenoma patients.

PMID:34427226 | DOI:10.4103/ijo.IJO_2086_20

Sci Rep. 2021 Aug 23;11(1):17062. doi: 10.1038/s41598-021-96366-9.

ABSTRACT

Acute myocardial infarction (AMI) is a major public health problem. Cold winter weather increases the risk of AMI, but factors influencing susceptibility are poorly known. We conducted an individual-level case-crossover study of the associations between winter cold spells and the risk of AMI, with special focus on survival at 28 days and effect modification by age and sex. All 16,071 adult cases of AMI among the residents of the city of Kaunas in Lithuania in 2000-2015 were included in the study. Cold weather was statistically defined using the 5th percentile of frequency distribution of daily mean temperatures over the winter months. According to conditional logistic regression controlling for time-varying and time-invariant confounders, each additional cold spell day during the week preceding AMI increased the risk of AMI by 5% (95% CI 1-9%). For nonfatal and fatal cases, the risk increase per each additional cold spell day was 5% (95% CI 1-9%) and 6% (95% CI – 2-13%), respectively. The effect estimate was greater for men (OR 1.07, 95% CI 1.02-1.12) than for women (OR 1.02, 95% CI 0.97-1.08), but there was no evidence of effect modification by age. Evidence on factors increasing susceptibility is critical for targeted cold weather planning.

PMID:34426618 | DOI:10.1038/s41598-021-96366-9

RMD Open. 2021 Aug;7(3):e001759. doi: 10.1136/rmdopen-2021-001759.

ABSTRACT

OBJECTIVES: To describe the relations between baseline clinical characteristics of the Applied Public-Private Research enabling OsteoArthritis Clinical Headway (IMI-APPROACH) participants and their predicted probabilities for knee osteoarthritis (OA) structural (S) progression and/or pain (P) progression.

METHODS: Baseline clinical characteristics of the IMI-APPROACH participants were used for this study. Radiographs were evaluated according to Kellgren and Lawrence (K&L grade) and Knee Image Digital Analysis. Knee Injury and Osteoarthritis Outcome Score (KOOS) and Numeric Rating Scale (NRS) were used to evaluate pain. Predicted progression scores for each individual were determined using machine learning models. Pearson correlation coefficients were used to evaluate correlations between scores for predicted progression and baseline characteristics. T-tests and χ² tests were used to evaluate differences between participants with high versus low progression scores.

RESULTS: Participants with high S progressions score were found to have statistically significantly less structural damage compared with participants with low S progression scores (minimum Joint Space Width, minJSW 3.56 mm vs 1.63 mm; p<0.001, K&L grade; p=0.028). Participants with high P progression scores had statistically significantly more pain compared with participants with low P progression scores (KOOS pain 51.71 vs 82.11; p<0.001, NRS pain 6.7 vs 2.4; p<0.001).

CONCLUSIONS: The baseline minJSW of the IMI-APPROACH participants contradicts the idea that the (predicted) course of knee OA follows a pattern of inertia, where patients who have progressed previously are more likely to display further progression. In contrast, for pain progressors the pattern of inertia seems valid, since participants with high P score already have more pain at baseline compared with participants with a low P score.

PMID:34426541 | DOI:10.1136/rmdopen-2021-001759

Sci Rep. 2021 Aug 23;11(1):17011. doi: 10.1038/s41598-021-96177-y.

ABSTRACT

Recent work has highlighted that people who have had TIA may have abnormal motor and cognitive function. We aimed to quantify deficits in a cohort of individuals who had TIA and measured changes in their abilities to perform behavioural tasks over 1 year of follow-up using the Kinarm Exoskeleton robot. We additionally considered performance and change over time in an active control cohort of migraineurs. Individuals who had TIA or migraine completed 8 behavioural tasks that assessed cognition as well as motor and sensory functionality in the arm. Participants in the TIA cohort were assessed at 2, 6, 12, and 52 weeks after symptom resolution. Migraineurs were assessed at 2 and 52 weeks after symptom resolution. We measured overall performance on each task using an aggregate metric called Task Score and quantified any significant change in performance including the potential influence of learning. We recruited 48 individuals to the TIA cohort and 28 individuals to the migraine cohort. Individuals in both groups displayed impairments on robotic tasks within 2 weeks of symptom cessation and also at approximately 1 year after symptom cessation, most commonly in tests of cognitive-motor integration. Up to 51.3% of people in the TIA cohort demonstrated an impairment on a given task within 2-weeks of symptom resolution, and up to 27.3% had an impairment after 1 year. In the migraine group, these numbers were 37.5% and 31.6%, respectively. We identified that up to 18% of participants in the TIA group, and up to 10% in the migraine group, displayed impairments that persisted for up to 1 year after symptom resolution. Finally, we determined that a subset of both cohorts (25-30%) experienced statistically significant deteriorations in performance after 1 year. People who have experienced transient neurological symptoms, such as those that arise from TIA or migraine, may continue to experience lasting neurological impairments. Most individuals had relatively stable task performance over time, with some impairments persisting for up to 1 year. However, some individuals demonstrated substantial changes in performance, which highlights the heterogeneity of these neurological disorders. These findings demonstrate the need to consider factors that contribute to lasting neurological impairment, approaches that could be developed to alleviate the lasting effects of TIA or migraine, and the need to consider individual neurological status, even following transient neurological symptoms.

PMID:34426586 | DOI:10.1038/s41598-021-96177-y