Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma.

BACKGROUND: To evaluate the safety and efficacy of the Minimally Invasive Micro Sclerotomy (MIMS) procedure in the management of uncontrolled open-angle glaucoma. METHODS: A prospective, open-label, single-arm clinical evaluation with intra-subject comparisons performed at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. Included were adults with primary open-angle glaucoma (OAG) (N = 114) or exfoliative glaucoma (N = 6) who were uncontrolled (IOP > 21) on tolerated topical medication. Mild (N = 7), moderate (N = 66) and severe (n = 47) cases were prospectively included without preselection. Following subconjunctival Mitomycin C, an ab-interno MIMS procedure was performed alone (N = 100) or combined with phacoemulsification (N = 20). Patients were followed for 52 weeks. Procedure-related complications and adverse events were recorded. Success criteria were defined as -5 < IOP ≤ 21mmHg OR a reduction in IOP of ≥ 20% from baseline with (qualified success) or without (complete success) hypotensive medications. RESULTS: Mean patient age was 69 ± 10.1 years. The mean duration of the procedure was 2:01 ± 0:41 min:sec. Scleral drainage channels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Iris plugging of the sclerostomy site and early spikes in IOP were the most common adverse events. The only reason for failure was final IOP > 21 mmHg on tolerated medication. At 52 weeks (n = 93), mean IOP decreased by 38% from baseline (P < 0.001), from 27.9 ± 3.7 to 17.5 ± 5.3 mmHg, a difference of 10.5 mmHg (95% CI: -11.7, -9.3). One-year qualified success was documented in 82.1% (95% CI: 72.9%,89.2%) of the patients and complete success, in 70.5% (60.3-79.4%). 60% (95 CI:49.4%,69.9%) of the patients achieved maximum IOP level of 14 mmHg or at least 30% reduction in IOP. CONCLUSIONS: MIMS procedure is a relatively simple, short and safe minimally invasive bleb-forming procedure. Its efficacy, as found in this short-term evaluation, lends it suitable for mild and moderate uncontrolled open-angle glaucoma patients. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04503590 2019-05-29.

The laboratory profile in idiopathic intracranial hypertension.

While overweight and female gender play an undisputable role in the pathogenesis of idiopathic intracranial hypertension (IIH), the contribution of other factors is still unclear. We have evaluated the laboratory findings of patients with IIH in an attempt to find the influence of abnormalities on the disease course. Included were 82 females after menarche and males older than 18 years who were followed up for at least 1 year. A wide range of laboratory parameters were examined at the time of presentation. The most frequent abnormal laboratory findings were elevated C reactive protein (CRP) (51 %), thrombophilia (31 %), increased plasma cortisol levels (29 %) and elevated lactate dehydrogenase (LDH) (20 %). Patients with elevated CRP and patients with thrombophilia had an unfavorable visual outcome. Increased cortisol levels and abnormal calcium correlated with a higher rate of recurrence. The visual outcome of patients with elevated LDH was better than those with normal LDH. It seems that certain metabolic, inflammatory and coagulation abnormalities may influence the course of IIH. If confirmed in further studies, these findings could contribute to elucidation of the etiology and prognosis of IIH.

Comparison between Hardy-Rand-Rittler 4th edition and Ishihara color plate tests for detection of dyschromatopsia in optic neuropathy.

BACKGROUND: The aim of this work was to compare the specificity-sensitivity balance of the Hardy-Rand-Rittler (HRR) 4th edition with the Ishihara color plate tests for color-vision defects in patients with optic neuropathy. METHODS: This is a prospective case-control study. The study group included 43 patients (48 eyes) with newly diagnosed optic neuropathy, and the control group included 33 patients (33 right eyes) who were referred to the eye clinic for conditions other than optic nerve or retinal macular disorders. Individuals with visual acuity of less than 20/70 (0.54 Log MAR) were excluded. All patients underwent comprehensive eye examination and color-vision evaluation with both tests in a random order under standardized lighting conditions. The scores of the Ishihara and HRR tests were set as the number of plates identified out of 12 and six respectively. RESULTS: The receiver operating characteristics (ROC) curve was statistically significantly better when using the HRR test (area under curve [AUC] = 0.93 ± 0.03) than for the Ishihara test (AUC = 0.77 ± 0.05) (P = 0.0006). The best specificity-sensitivity balance for the HRR was 100 % and 79 % respectively, and for the Ishihara test 100 % and 48 % respectively. CONCLUSIONS: The HRR 4th edition test proved to be superior to the Ishihara test in detecting acquired dyschromatopsia due to optic neuropathy. We recommend using the HRR 4th edition test as a screening method for detection of color-vision defects in patients with optic neuropathy.

Diagnosis of posttraumatic stress disorder after surgery for primary rhegmatogenous retinal detachment.

PURPOSES: To investigate the prevalence of posttraumatic stress disorder (PTSD) in patients who underwent surgery for primary rhegmatogenous retinal detachment and to explore variables associated with the disorder. METHODS: Subjects eligible for the study were patients aged 18 years or older, who underwent surgery for primary rhegmatogenous retinal detachment at the Goldschleger Eye Institute, from January 1, 2004, to December 31, 2009, and were followed for at least 1 month. Study patients were screened for the existence of PTSD symptoms via a telephone survey, and positively identified patients were asked to undergo a structured psychiatric interview. Posttraumatic stress disorder was assessed by the Clinician Administered PTSD Scale, and the 25-item National Eye Institute visual function questionnaire (NEI-VFQ-25) was used as a measure of vision-related quality of life. Objective clinical measures were obtained from the patient's medical records. Clinical variables were compared between PTSD-diagnosed patients, patients who were screened for PTSD but were found to be PTSD negative in the interview (false-positive group), and patients who were found negative for PTSD in the screening survey. RESULTS: Of the 547 eligible patients, 366 were enrolled in the study. Nine patients (2.5%) met the criteria for PTSD diagnosis. Posttraumatic stress disorder patients reported significantly more traumatic events in their past (P = 0.015), and for these patients, NEI-VFQ-25 composite score was significantly lower (P < 0.001). Clinical measures were not found as independent risk factors for PTSD prediction. CONCLUSION: Posttraumatic stress disorder may develop in the aftermath of primary rhegmatogenous retinal detachment. Previous traumatic events and NEI-VFQ-25 scores were found as independent risk factors for PTSD prediction.

Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure.

PRCIS: Intermediate-term results suggest that ab interno Minimally Invasive Micro Sclerostomy (MIMS) stent-less subconjunctival filtration procedure is a promising treatment option for patients with open-angle glaucoma (OAG). PURPOSE: MIMS is a novel ab interno, stent-less, subconjunctival filtration procedure. This study set to investigate the safety, performance, and efficacy of MIMS in OAG patients. METHODS: Prospective, open-label, single arm clinical trial with intrasubject comparisons. Study participants were adults with OAG who were candidates for a filtration procedure. Patients were operated by a single surgeon (A.A.) in Chennai, India. Following mitomycin-C pretreatment, ab interno MIMS procedure was performed alone or combined with phacoemulsification surgery. Procedure-related complications and adverse events were assessed. Primary outcomes: patients (%) achieving an intraocular pressure (IOP) ≥5 mm Hg and ≤18 mm Hg, and an IOP reduction of >20% as compared with baseline, with or without hypotensive medications, with no need for recurrent surgery. RESULTS: Twenty-one phacoemulsification-MIMS and 10 standalone MIMS procedures were performed. Mean age was 63.94±6.33 years. Mean duration of MIMS was 1:58±0:25 (min:s). Scleral tunnels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Five (16.12%) patients presented with iris clogging 1 to 24 weeks following procedure. Two were treated with laser and 3 required trabeculectomy. Mean IOP change from baseline at 24 weeks was 47.4% (31.2 to 16.4 mm Hg, P<0.0001, n=23). The mean difference was -14.8 mm Hg (95% confidence interval: -17.6, -11.9) with no statistically significant differences between groups. Qualified success was achieved in 21 (84%), 17 (74%), and 13 (93%) after 12, 24, and 52 weeks, respectively. Complete success was achieved in 17 (68%), 13 (57%), and 8 (57%) after 12, 24, and 52 weeks, respectively. CONCLUSIONS: The interim results suggest that MIMS procedure may be a simple and effective surgical option for early OAG patients requiring target IOP in high teens although iris clogging of incision site is the major concern with this procedure.

MIMS Procedure: Concept and Evaluation of Safety, Feasibility, and Efficacy in a Porcine Experimental Model.

PRECIS: We present a novel stentless filtration system used to create a permanent sclerocorneal drainage channel that reduces intraocular pressure (IOP) without the need to create a conjunctival incision or a scleral flap. PURPOSE: The purpose of this study was to evaluate the safety, feasibility, and preliminary performance of a novel surgical system, the minimally invasive micro sclerostomy (MIMS), in an in vivo porcine experimental model. MATERIALS AND METHODS: MIMS is an ab externo stentless filtration procedure. An activation system is used to operate a handpiece that includes a 600 µm needle containing an injectable 300 µm triangular blade that spins around its longitudinal axis. The needle is inserted into the subconjunctival space and the blade is injected at the limbal area creating a drainage channel at the sclerocorneal junction, connecting the anterior chamber to the subconjunctival space. The first generation of the MIMS surgical system was assessed in a porcine experimental model, firstly on 6 pigs and thereafter on 10 pigs. All adverse events, IOP measurements, and bleb descriptions were recorded for up to 14 weeks. The shape and location of the scleral tunnel, the subconjunctival bleb, and the healing process were examined by slit-lamp examination, by histopathologic analysis, and by anterior segment optical coherence tomography imaging. RESULTS: No device malfunctions were recorded. Scleral tunnels were repeatedly achieved in all models. No significant intraoperative or postoperative complications were recorded. Effective fluid percolation was achieved in all eyes. The mean IOP statistically significantly decreased from 19.0±3.2 mm Hg preoperatively to 11.1±4.9 mm Hg on the first follow-up visit (P=0.0046) in the first leg of the study, and from 18.5±3.8 to 13.3±1.9 mm Hg in the second leg (P=0.0165). In both, IOP gradually returned to preoperative values toward the end of the follow-up period, as expected in a porcine experimental model. Histologic analysis of the analyzed tissue was not associated with significant tissue reaction. CONCLUSIONS: The MIMS procedure exhibited a consistent and relatively high safety, feasibility, and efficacy profiles. In the future, the MIMS procedure may provide a novel solution for uncontrolled IOP.

The relationship between patient age and astigmatism magnitude after congenital cataract surgery.

PURPOSE: To evaluate the magnitude of refractive astigmatism after congenital cataract surgery and to define its correlation with patient age. METHODS: The authors retrospectively reviewed the charts of all pediatric patients who underwent congenital cataract extraction with intraocular lens (IOL) implantation through a 3.0-mm clear corneal incision from 1998 to 2003, and had no suture removal for 5 months afterward. Thirty-four children were included, aged 2 months to 15 years. Refractive astigmatism was assessed manually 1 week, 3 months, and 5 months after surgery by an experienced optometrist. The paired t test was used to compare the magnitude of postoperative astigmatism at different postoperative periods. Spearman correlation was used to determine the correlation between patient age and the postoperative refractive astigmatism. RESULTS: Mean refractive astigmatism in all patients was 1.8+/-1.5 diopters (D) at 1 week postoperatively. It significantly decreased to 1.0+/-0.7 D at 3 months postoperatively (p=0.001), and to 0.8+/-0.7 D at 5 months postoperatively (p=0.03). The change in astigmatism was significantly greater during the first 3 postoperative months than during the following 2 months (p=0.04). Patient age was significantly correlated with 1 week postoperative astigmatism (Spearman coefficient, r = -0.46; p=0.006) and with 3 months postoperative astigmatism (Spearman coefficient, r =-0.37; p=0.03). CONCLUSIONS: Congenital cataract surgery using a small, clear corneal incision for IOL implantation caused high early postoperative astigmatism, which spontaneously regressed thereafter. Younger patients had higher early postoperative astigmatism.

A feasibility study of an Internet-based telemedicine system for consultation in an ophthalmic emergency room.

We examined the feasibility of a low-bandwidth, Internet-based tele-ophthalmology system for consultation in an ophthalmic emergency room. Forty-nine patients (98 eyes) with complicated cases were seen during night shifts in the ophthalmic emergency room. Ocular images were taken using a slit-lamp connected to a video camera, processed and transmitted to a senior physician by email. A telephone was used for real-time audio communication. Each case was re-examined by the same senior physician the following day. The time needed to capture and to process the images was 5 min (SD 2). Each case was given a feasibility score (0-100%), which was defined as the contribution made by the transmitted images in presenting clinical details which could not have been described verbally. High feasibility scores (mean scores ranging from 85 to 90) were found for the following images: ocular surface, anterior chamber, anterior chamber angle, pupils, lens, optic nerve and macula. In contrast, images of vitreous and peripheral retina received low feasibility scores (mean score 65). There was 100% agreement between the diagnosis made during consultation and the on-site examination made by the senior ophthalmologist later on. Ninety-eight percent of the patients stated that they would prefer being examined under the telemedicine system on their next emergency room visit, rather than the traditional resident on-site examination.

Needle revision of failed filtering blebs augmented with subconjunctival injection of mitomycin C.

OBJECTIVE: To evaluate the short-term efficacy and safety of needle revision of failed filtering blebs augmented with subconjunctival injection of mitomycin C. PATIENTS AND METHODS: Needle revision of failed filtering blebs followed by subconjunctival injection of 10 to 20 microg of mitomycin C was performed in 41 eyes. Short-term results were analyzed 6 months postoperatively. RESULTS: The mean (+/- standard deviation [SD]) intraocular pressure decreased from 26.4 +/- 6.2 to 16.4 +/- 6.5 mm Hg (P < .001), and the mean (+/- SD) number of medications decreased from 2.8 +/- 1.4 to 0.7 +/- 1.1 (P < .001). The overall success rate (defined as intraocular pressure between 5 and 21 mm Hg and no serious complications) was 76%. Initial intraocular pressure, number of previous surgical procedures, type of glaucoma, and lens status did not influence the success rate. The resulting bleb was significantly larger in the successful cases (2 +/- 0.8 vs 0.33 +/- 0.5; P < .001). Complications included one case of late suprachoroidal hemorrhage. The mean (+/- SD) visual acuity remained stable (delta visual acuity in Snellen lines = 0.023 +/- 1.1). CONCLUSION: Needle revision followed by subconjunctival injection of mitomycin C is an alternative to more complicated surgical procedures in cases of failed filtering blebs. Bleb formation was essential for successful reduction of intraocular pressure, which suggests subconjunctival injection of mitomycin C by itself may not lower intraocular pressure.

Intraocular pressure curves of untreated glaucoma suspects and glaucoma patients in sitting and lateral decubitus positions using the goldmann applanation tonometer.

PURPOSE: Evaluation of data obtained during diurnal intraocular pressure (IOP) measurements by means of the Goldmann Applanation tonometer in sitting and lateral decubitus positions. PATIENTS AND METHODS: Retrospective cohort study of 41 consecutive untreated subjects (82 eyes) with ocular hypertension or suspicious discs. The IOP was measured by Goldmann Applanation tonometer in sitting position at 9 AM, 12 AM, 3 PM, and 6 PM; and in right lateral decubitus position around 12:15 PM. RESULTS: In the right eye (RE) mean peak IOP was 22.19±4.68 mm Hg. In the left eye (LE) peak mean IOP was 22.19±3.8 mm Hg. In 91.5% of the eyes, the IOP increased in the lateral decubitus position. The average change in the RE was an increment of 4.22±2.67 mm Hg (P<0.001) and in the LE an increment of 3.51±3.11 (P<0.001). This increment was significantly higher in the dependent eye (i.e., lower eye) (P=0.049). Sixty-seven percent of eyes had a positional elevation of IOP between 2 and 5 mm Hg and 23.2% of eyes had IOP elevation between 6 and 12 mm Hg. In the great majority of the eyes (80.5% RE and 78% LE) the lateral decubitus IOP was greater than maximal diurnal sitting IOP. CONCLUSIONS: The IOP in the lateral decubitus position was significantly higher than the mean maximal diurnal sitting IOP. Over 20% of the patients had an IOP increase of ≥6 mm Hg when lying down. Timely identification of patients with excessive postural elevation of IOP could affect their management and prevent visual fields loss.

Endothelial cells and central corneal thickness after modified sutureless manual small-incision cataract surgery.

PURPOSE: Manual small-incision cataract surgery (MSICS) is a viable method for cataract surgery around the world. We evaluated the impact of a modification of MSICS, in which an anterior chamber maintainer is used throughout the surgery with the addition of ocular viscoelastic device prior to nucleus removal (M-MSICS), on the corneal endothelium.
 METHODS: This prospective study comprised patients randomly assigned for cataract surgery who underwent M-MSICS. Patients underwent corneal endothelial counts by a noncontact specular microscopy in the center and at 12 and 6 o'clock position as well as central corneal pachymetry (CCT) preoperatively, and at 1 week and 1 and 3 months postoperatively. 
 RESULTS: Twenty-one eyes were included, 16 of which completed the entire follow-up. There was a statistically significant difference in endothelial cell loss at the center of the cornea at 1 week postoperatively (p = 0.003). However, there was no significant difference in endothelial cell measurements between preoperative and other postoperative timepoints at the center of the cornea. In addition, no significant difference was found in the 12 and 6 o'clock measurements at all timepoints. There was a mild but statistically significant increase in CCT at the center of the cornea at 1-week and 1-month postoperative measurements as compared to preoperative measurement (p<0.05). By postoperative month 3, CCT had returned to baseline level. 
 CONCLUSIONS: Modified MSICS offers a viable enhancement of MSICS, with mild and transient impact on the corneal endothelial cell density and corneal pachymetry.

Reduced mesopic and photopic foveal contrast sensitivity in glaucoma.

OBJECTIVE: To demonstrate differences in foveal contrast sensitivity (CS) between glaucomatous and nonglaucomatous eyes using a simple, rapid computerized test. METHODS: This study included consecutive patients with glaucoma (35 eyes) and age-matched control participants (23 eyes) with visual acuity of 20/30 or better. Patients with any other ocular disease, including cataract, were excluded. All participants underwent a comprehensive ocular examination, perimetry, and CS. Contrast sensitivity was examined by means of 2 computerized psychophysical tests. The transient method included the presentation of a target in a temporal, 2-alternative, forced-choice procedure, and the static method involved 4 forced-choice procedures. The targets were Gabor patches with spatial frequencies of 1.5 to 9.0 cycles per degree. The tests were conducted under photopic and mesopic conditions. RESULTS: Significantly lower foveal CS was found in glaucomatous eyes under photopic and mesopic conditions for all spatial frequencies (P < .01). The transient and static methods yielded similar results and were significantly correlated (P < .001). All transient photopic and mesopic CSs were significantly correlated with cup to disc ratio (P < .05). The static photopic spatial frequency of 6 cycles per degree was significantly correlated with the severity of the glaucomatous damage. CONCLUSIONS: The results indicate that foveal CS is impaired in glaucoma despite good visual acuity, suggesting that central visual function damage occurs in glaucoma. The similarity between the 2 methods of testing implies that the static method, being the shorter and easier one, may be used in future research. Further research is necessary to establish a CS testing role in the screening and monitoring of glaucoma.

Retained lens fragments: nucleus fragments are associated with worse prognosis than cortex or epinucleus fragments.

PURPOSE: To identify factors that determined the outcome of eyes that underwent pars plana vitrectomy for retained lens fragments after phacoemulsification. METHODS: A retrospective review of the records of 63 eyes that underwent vitrectomy for retained lens fragments after phacoemulsification. Fragments were defined as nuclear if they contained any nucleus component or non-nuclear if they contained only cortex and epinucleus. Nuclear fragments were further divided into large (at least 1/3 the size of the nucleus) or small. RESULTS: A total of 67% of eyes had retained nuclear fragments and 33% had non-nuclear fragments. Of the eyes with nuclear fragments, 64% had large fragments and 36% had small fragments. Statistical analysis revealed that the lens fragment type was the major determinant of the final visual acuity (VA). Only 38.8% (14/36) of the eyes with nuclear fragments achieved final VA of 20/40 or better, compared with 77.7% (14/18) of eyes with non-nuclear fragments (p=0.007). All other parameters, including size of the nuclear fragment, were not correlated with final VA. The major complications encountered in this series were retinal detachment (12.6%), pseudophakic bullous keratopathy (6.3%), cystoid macular edema (15.8%), and glaucoma (15.8%). CONCLUSIONS: The major finding of our study is that posterior dislocation of nuclear lens fragments is associated with worse visual outcome than that of non-nuclear fragments. This may be related to a more complicated course of the cataract surgery, direct mechanical damage to the retina, a stronger inflammatory response, or a more traumatic vitrectomy procedure.

Trabeculectomy with brief exposure to mitomycin C.

BACKGROUND: To evaluate the safety and efficacy of primary trabeculectomy with brief exposure (15 s) to mitomycin C (MMC) (0.4 mg/mL). METHODS: Medical record review of all patients who underwent primary trabeculectomy with brief exposure to MMC at the Goldschleger Eye Institute in a 4-year period was performed. RESULTS: Sixty-three patients (35 men, mean age of 55 years) underwent trabeculectomy with brief exposure to MMC. Intraocular pressure (IOP) decreased a mean +/- standard deviation of 17.9 +/- 9.6 mmHg from 30.4 +/- 9.5 mmHg preoperatively to 12.5 +/- 6.2 mmHg postoperatively after a mean follow up of 18.3 months (P < 0.001). Number of antiglaucoma medications decreased from 2.9 +/- 1.1 preoperatively to 0.2 +/- 0.4 postoperatively (P < 0.001, paired samples t-test). Complete success, defined as IOP < 18 mmHg without antiglaucoma medication, was achieved in 46 patients (73%) and qualified success, defined as IOP

Intraocular pressure is low in eyes with giant cell arteritis.

BACKGROUND: Although ocular ischemia occurs in giant cell arteritis (GCA), intraocular pressure (IOP) has not been systematically evaluated as a diagnostic sign. METHODS: We conducted a retrospective, case-controlled, observational study of IOP in patients with ocular manifestations of GCA (GCA patients), age-matched patients diagnosed with nonarteritic ischemic optic neuropathy (NAION patients), and age-matched patients with cataract (control patients). Medical records were examined for all consecutive patients with the diagnosis of GCA from 1995 to 2004 (n = 16) and NAION from 2002 to 2004 (n = 16) and for patient candidates for cataract extraction (n = 16). The eye intended for cataract extraction was chosen as the "affected eye" in the control patients. RESULTS: The mean IOP in the affected eye of 16 GCA patients was 11.9 mm Hg, significantly lower than the 15.1 mm Hg in affected eyes of age-matched NAION patients and 15.8 mm Hg in control patients (P = 0.002). At presentation, 5 GCA patients had IOP < 10 mm Hg (mean 6.8 mm Hg) without other signs of anterior segment ischemia. None of the NAION or control patients displayed such low IOPs. CONCLUSIONS: IOP was significantly lower in the patients with GCA than in patients with NAION or cataract. Hypotony occurred in one third of GCA patients without other signs of anterior ocular ischemia. These findings suggest that low IOP may be a distinguishing factor between GCA and NAION in patients with ischemic optic neuropathy, but evaluation of a larger group of patients is needed for confirmation.