Efficacy and safety analysis of intravitreal bio-similar products of bevacizumab in patients with macular edema because of retinal diseases.

Purpose: The purpose of this study was to evaluate retrospectively the efficacy and safety profile of intravitreal injection of bevacizumab bio-similar product Zybev(Z) for macular edema because of retinal diseases. Methods: A retrospective analysis was conducted on patients with macular edema because of retinal diseases, who had been administered intravitreal injections of bio-similar bevacizumab at a tertiary eye care center. Changes in the retinal thickness and visual acuity were evaluated to judge the efficacy, and adverse events were noted for the safety profile over a period of 6 weeks. Results: A total of 104 patients were included in the study. The mean age of the patients was 53 ± 13.5 years. The mean pre-injection best corrected visual acuity (BCVA) was 1.32 ± 0.70 log minimum angle of resolution (logMAR) with a central subfield thickness (CST) of 429.26 ± 204.30 µm, and the post-injection BCVA at 6 weeks was 1.13 ± 0.71 logMAR with a CST of 302.26 ± 104.50 µm; this change was statistically significant (P < 0.05) for all groups. The mean average cube thickness (µm) decreased from 11.85 ± 1.96 pre-injection to 10.52 ± 1.75 post-injection, and the mean average cube volume (mm3) decreased from 329.30 ± 54.35 to 302.23 ± 49.56 (P < 0.05). During the follow-up period after injection, no patient had inflammation, endophthalmitis, an increase in intra-ocular pressure, or systemic side effects. Conclusion: This short-term retrospective analysis provides evidence regarding the efficacy and safety of intravitreal injection of bio-similar products of bevacizumab for the treatment of macular edema because of retinal diseases.

Corneal endothelial changes following cataract surgery in hard nuclear cataract: Randomized trial comparing phacoemulsification to manual small-incision cataract surgery.

Purpose: To evaluate and compare endothelial cell changes in phacoemulsification and manual small-incision cataract surgery (MSICS) in patients with uncomplicated senile cataracts. Methods: This was a prospective: , tertiary care hospital-based, randomized, double-blinded interventional study. In total, 152 patients with an uncomplicated senile cataract of nuclear grade III and above were recruited. Exclusion criteria included patients with preoperative endothelial cell density (ECD) less than 1500 cells/mm3, a history of previous ocular surgery, any other coexisting ocular disease, and intraoperative or postoperative surgical complications. Preoperative and postoperative values of ECD and central corneal thickness (CCT) were measured, analyzed, and correlated with various factors. Results: Patients were randomized into two interventional groups-MSICS and phacoemulsification. Factors associated with significant drop in postoperative ECD following phacoemulsification were patients with advanced age (P = 0.01), higher grades of cataract (P = 0.01), and longer effective phacoemulsification time (P = 0.007). Shallow anterior chamber depth (ACD) was strongly associated with greater ECD loss in both groups (P < 0.0001). A threshold value of 2.86 mm of ACD was defined for minimal endothelial cell loss following phacoemulsification. CCT was observed to slightly increase postoperatively in both groups but was insignificant (P > 0.05). Conclusion: Both MSICS and phacoemulsification have similar postoperative visual outcomes. An increase in postoperative CCT is insignificant following surgery. Greater postoperative ECD loss is associated with phacoemulsification with advanced age, hard nuclear cataracts, and longer effective phacoemulsification time. ACD can be used as an essential parameter preoperatively to determine the choice of surgical technique between MSICS and phacoemulsification.

Comparative clinical trial of intracameral ropivacaine vs. lignocaine in subjects undergoing phacoemulsification under augmented topical anesthesia.

Purpose: To compare intracameral Ropivacaine to Lignocaine during phacoemulsification under augmented topical anesthesia, in terms of efficacy and safety. Methods: This prospective, randomized, double-masked clinical trial included subjects planned for phacoemulsification with posterior chamber intraocular lens implantation for visually significant uncomplicated senile cataract, under augmented topical anesthesia. Cases were randomized into two groups, Group A (Ropivacaine 0.1%) or Group B (Lignocaine 1.0%). The pain experienced by the patients during the surgery, mydriasis, post-op inflammation and endothelial cell change at six weeks after the procedure was evaluated. Surgeon's feedback was recorded to evaluate the cooperation of the patient during surgery. Results: A total of 210 subjects were screened and 184 were randomized to have 92 subjects in each group. There was no statistically significant difference seen on comparing Group A and B with respect to Age (P = 0.05), painful surgical steps (P = 0.85), visual analog scale scores (P = 0.65), surgeon's score (P = 0.11), postoperative inflammation (P = 0.90) and average ultrasound time during phacoemulsification (P = 0.10). Subjects in Group A fared better when compared to Group B with respect to endothelial cell loss (P = 0.0008), and augmentation in mydriasis (P < 0.001). Conclusion: Intracameral Ropivacaine and Lignocaine, both are equally effective in providing analgesia during phacoemulsification. However, intracameral Ropivacaine is superior to Lignocaine with regards to corneal endothelial cell safety, and augmenting mydriasis.

Jalili syndrome presenting with situs inversus totalis and keratoconus: the first case in the Indian subcontinent.

Jalili syndrome (JS) (MIM#217080) is a rare genetic disorder characterized by the comorbid appearance of cone-rod dystrophy (CORD) and amelogenesis imperfecta (AI). JS is an autosomal recessive inherited disorder caused by different mutations, all with a linkage at achromatopsia locus 2 q11 on the metal transporter gene CNNM4. The case report presented here describes JS with distinct phenotypic variations such as situs inversus totalis (SIT) along with additional ophthalmic findings such as keratoconus and ectopia lentis. It is the first case of JS reported from the Indian subcontinent, affecting a male patient of Muslim faith from an area having high fluoride levels in the ground water. A positive history of consanguineous marriage among his family members of past generations was also evident.

A simplified approach for placing the iris disc on a custom made ocular prosthesis: report of four cases.

This case report describes a series of four cases of different age group, in which a simplified approach was applied for positioning the iris disc on a custom made ocular prosthesis. For each of the patient, a pre-fabricated eye was selected; whose iris and pupil closely matched that of the natural eye. This was duplicated for use as a tray in impression procedure. Iris portion of the stock eye was trimmed out and oriented on the cast according to previously transferred pupillary mark. This stock eye-wax pattern combination was tested in the eye socket, modified accordingly and finally cured in transparent heat cured acrylic resin. The technique to fabricate ocular prosthesis in present case reports modifies pre-fabricated eye prosthesis to a custom-made fit and aesthetics. This helped us to overcome the disadvantages of poor fit, inadequate movement and complex painting procedure and technique involved in making a custom-made ocular prosthesis. It can be concluded that close adaptation of the custom-made ocular prosthesis to the tissue bed provides maximum comfort and restores full physiologic function to the accessory organs of the eye.

Prosthetic guidelines for ocular rehabilitation in patients with phthisis bulbi: a treatment-based classification system.

Prosthetic rehabilitation of phthisis bulbi defects is the only treatment option for cosmetic rehabilitation of patients with such defects. Currently, there is no treatment-based classification for prosthetic rehabilitation of patients with phthisis bulbi. Phthisical ocular defects and/or prosthetic rehabilitation were evaluated in an attempt to establish prosthetic guidelines that could be organized into a classification system. Fifty patients who received rehabilitation for phthisis bulbi were reviewed. Phthisis bulbi defects were divided into 4 classes. All the patients had rehabilitation, depending upon the class to which they were assigned. The aim of this treatment-oriented classification system was to organize and define the complex nature of the restorative decision-making process for patients with phthisis bulbi.

Phacoemulsification without preoperative topical mydriatics: induction and sustainability of mydriasis with intracameral mydriatic solution.

CONTEXT: Intracameral mydriatic solution can eliminate the disadvantages of repeated eye drop instillation regimen and provide adequate mydriasis for phacoemulsification with added advantages. AIMS: Evaluating the role of intracameral irrigating solution (0.5% lignocaine + 0.001% epinephrine) in initiating and maintaining the pupillary mydriasis during phacoemulsification. Secondary aims were to observe the effect of surgical time, nucleus density and ultrasound time on mydriasis during the procedure. SETTINGS AND DESIGN: The study is a prospective interventional case series, conducted at tertiary care institution. MATERIALS AND METHODS: Thirty patients underwent phacoemulsification under topical anesthesia for visually significant cataract. Pupillary dilatation was achieved by intracameral irrigation of mydriatic solution alone. Pupillary diameter was measured serially during surgery and ultrasound time and total surgical time were noted. STATISTICAL ANALYSIS USED: Paired samples student-t test was done to compare means. Spearman correlation coefficient was used to study the effect of various parameters on mydriasis. RESULTS: Thirty eyes completed the study. The pupil size increased from 2.1 mm (Range 2-3.5 mm SD ± 0.32) to 6.9 mm (Range 5-9 mm SD ± 1.02) in 30 seconds time after intracameral mydriatic solution delivery, and was 7.0 mm (Range 3.5 - 9 mm SD ± 0.20) at the end of surgery. Duration of surgery, grade of nucleus and ultrasound time had statistically insignificant effect on mydriasis. CONCLUSIONS: Intracameral solution containing 0.5% lignocaine and 0.001% epinephrine provides rapid mydriasis which is adequate for safe phacoemulsification and is unaffected by other parameters.

A novel technique to recanalize the nasolacrimal duct with endodiathermy bipolar probe.

AIMS: To evaluate a new approach for recanalization (RC) of nasolacrimal duct obstruction in the treatment of the symptomatic nasolacrimal duct obstruction (NLDO). MATERIALS AND METHODS: A prospective, interventional, comparative study in 302 eyes of 209 patients of symptomatic nontraumatic NLDO. Eyes with previous failed surgery were excluded. One hundred and fifty-one eyes underwent RC with 20 G endodiathermy bipolar probe connected to a 7 W diathermy followed by bicanalicular intubation under direct visualization. One hundred and fifty-one eyes underwent standard external dacryocystorhinostomy (DCR). Follow-up was for 24 months and evaluation was done on basis of change in symptoms and lacrimal syringing. Data was analyzed by Chi-square test and unpaired t-test. P value < 0.05 was considered statistically significant. RESULTS: Success defined as an asymptomatic patient or freely patent syringing was 92.7% (140 eyes) in RC group and 83.44% (126 eyes) in DCR group. Success was significantly more (P ≤ 0.01) in RC than DCR group. Surgical time was significantly less in RC than DCR (P ≤ 0.001). In RC group, RC could not be performed in three eyes and had to be later taken up for DCR. Intubation after RC was not achieved in four eyes; however these eyes had a patent pathway till 24 months. Twenty-two eyes had a premature extrusion of the tube; but the success rate in these (20 eyes) was comparable to the others within the group (P > 0.05). Two eyes in RC and one in DCR group had complications. CONCLUSIONS: RC with 20 G endodiathermy bipolar probe is a quick, simple, and effective alternative to standard external DCR.

Microbiological and clinical characteristics of diabetic foot infections in northern India.

INTRODUCTION: India has the largest diabetic population of 50.8 million that could reach an epidemic proportion by 2030. Diabetic foot infection is one of the dreaded complications of diabetes.  Only a few studies that focus on patterns of diabetic foot infection in our region, where diabetic foot care is inadequate, are available. This study evaluated microbial and clinical characteristics of diabetic foot infections that will be helpful in taking appropriate measures for their management. METHODOLOGY: In this prospective study conducted during 2008-2009, sixty-two diabetic foot patients underwent detailed history, clinical examination, and laboratory investigations including parameters of systemic infections. Microbial culture and sensitivity were performed at the time of presentation. RESULTS: Among 62 cases, 43.5% had mono-microbial infection, 35.5% had poly-microbial infections, and 21% had sterile culture. Among 82 bacteria isolated, 68% were Gram negative and 32% were Gram positive. Leukocyte counts were higher (16928±9642 versus 14593±6687 cells/mm(3)) and haemoglobin (7.9±2.4 versus 9.2±2.2 mg/dl) lower in poly-microbial compared to mono-microbial infections. Haemoglobin counts were lower and leukocyte counts higher in Gram-negative compared to Gram-positive infections. Patients with sterile cultures also had clinical evidence of persistent infection. Escherichia coli were the most common isolate and piperacillin/tazobactam showed highest sensitivity. CONCLUSIONS: Gram-negative bacteria were most prevalent in diabetic foot infection. It is not uncommon to have culture reports negative despite clinical evidence of infection. This study suggests that piperacillin/tazobactam should be the treatment of choice on an empirical basis prior to a definitive bacteriological study and in cases with negative culture reports.

Transcanalicular laser dacryocystorhinostomy using low energy 810 nm diode laser.

BACKGROUND: Hypertrophic scarring may be a cause of failure after transcanalicular laser dacryocystorhinostomy (DCR) surgery. This hypertrophic scarring results from tissue charring and excessive coagulation, which may be caused by the high laser energy. We have evaluated the use of low energy settings to prevent hypertrophic scarring, for a successful outcome. AIMS: To perform and evaluate transcanalicular laser DCR using low energy 810 nm diode laser. DESIGN: Interventional, non-comparative, case series. MATERIALS AND METHODS: Patients with nasolacrimal duct obstruction and chronic dacryocystitis, who needed DCR, and were fit for surgery under local anesthesia, were recruited to undergo transcanalicular laser DCR using a 810 nm diode laser. The outcome was measured by the patency of the lacrimal passage, as indicated by the relief in the symptoms and the patency on syringing at the last follow-up. The surgical time and surgical complications were noted. STATISTICAL ANALYSIS USED: Descriptive analysis. RESULTS: The study included 94 patients. The average age was 30.1 years (range 15 - 69 years). Seventy (74.4%) patients were female. Eight patients had failed external DCR. Per-operative patency of the passage was obtained in all the patients. Average surgical time was seven minutes (5 - 18 minutes). At the end of the study period of one year, a successful outcome was seen in 85 patients (90.5%). There were eight patients of previous failed DCR surgeries, and six of them achieved a cure at the end of follow-up. CONCLUSIONS: Transcanalicular Laser DCR can be safely performed using a low power 810 nm diode laser. The surgery is elegant, minimally invasive, allows fast rehabilitation, and has an excellent success rate.

Cataract surgery under topical anesthesia using 2% lignocaine jelly and intracameral lignocaine: is manual small incision cataract surgery comparable to clear corneal phacoemulsification?

A prospective comparative study was undertaken to compare the patients' pain experience, surgical outcome and surgeon's experience in phacoemulsification and manual small incision cataract surgery (MSICS) under topical anesthesia supplemented with intracameral lignocaine (TASIL). In Group 1 (n=88) phacoemulsification was done and in Group 2 (n=92) MSICS was done. Pain scores were marked by the patients on a Visual analog scale (VAS) after the surgery. The surgical experience was noted on a questionnaire by the operating surgeon. Descriptive analysis and one-tailed Mann-Whitney test were used to draw results. The average VAS score in Group 1 was 0.65 (SD 1.31) and in Group 2 it was 0.90 (SD 1.22). This difference in the average was not statistically significant with P=0.09. The study demonstrates that MSICS and phacoemulsification both can be done safely under TASIL with acceptable patient comfort, and the pain experienced by the patients during the procedures is comparable.