Journal of cataract and refractive surgery最新文献

Purpose: To evaluate the effectiveness and safety of a crosslinked hyaluronate (HA) canalicular filler (Lacrifill Canalicular Gel) compared with a commercially available hydrogel canalicular plug (Form Fit).

Setting: 5 sites in the United States.

Design: Prospective, multicenter, controlled, double-masked, randomized 2:1 (filler:plug).

Methods: Adults (≥22 years) with the Schirmer test (with anesthesia) ≤10 mm/5 minutes, presence of corneal staining, ocular surface disease index (OSDI) of ≥23 with ≤3 responses of "not applicable," patent lacrimal drainage system, and bilateral corrected distance visual acuity of 20/40 or better. Filler or plugs were instilled bilaterally in the inferior canaliculi. Primary effectiveness endpoint was noninferiority of the mean within subject change from baseline to month 3 in Schirmer score for patients receiving filler compared with plugs. The key secondary effectiveness endpoint was noninferiority of the proportion of patients with filler achieving improvement from baseline to month 3 in OSDI by a minimal clinically important difference. Additional endpoints included the mean change from baseline to 3 and 6 months in tear meniscus height, OSDI, corneal staining, tear breakup time, and safety.

Results: 157 patients were randomized; 99 patients with crosslinked HA filler and 52 patients with hydrogel plugs completed the study. Filler was noninferior to plugs in the mean Schirmer score change from baseline and in the proportion of patients achieving a clinically important improvement in OSDI.

Conclusions: Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months.

Purpose: To evaluate microbiological cultures of cataract surgical devices and products that were reused for multiple cases.

Setting: Aravind Eye Hospital, Pondicherry, Tamil Nadu, India.

Design: Prospective cohort study.

Methods: Samples from multiple surgical instruments and products that were reused for consecutive cataract surgeries underwent bacterial and fungal cultures and were monitored alongside positive controls for 7 days. This included instruments that were processed using immediate use steam sterilization (IUSS) between cases (eg, surgical cannulas, syringes, phacoemulsification and coaxial/bimanual irrigation/aspiration [I/A] tips, phacoemulsification and I/A sleeves) (Group 1), instruments that were used without sterilization between cases (eg, phacoemulsification tubing/handpieces, coaxial I/A handpieces) (Group 2), and the residual (unused) fluid from balanced salt solution bags after being used for multiple patients (Group 3).

Results: 3333 discrete samples were collected from all 3 product groups that were reused across multiple patients. In all collected samples, no bacterial or fungal growth was observed. Of the 3241 cataract surgeries that used reused and IUSS-sterilized instruments alongside instrument sets cultured on the same day and balanced salt solution bags shared across multiple patients, no eyes developed endophthalmitis over a 6-week follow-up period.

Conclusions: Bacterial or fungal growth was not found in extensive microbiological cultures of IUSS-sterilized ophthalmic surgical instruments and cataract surgical products that were reused in multiple patients. This microbiological data complements clinical endophthalmitis data from 2 million consecutive cases at the Aravind Eye Hospital, suggesting that their instrument and surgical supply processing practices may allow for safe and sustainable ophthalmic care.

Purpose: To develop and assess the utility of an ophthalmic viscosurgical device (OVD) manufactured with fluorescein-conjugated hyaluronic acid (conjHA).

Setting: Department of Biomedical Engineering and the Wilmer Eye Institute, Johns Hopkins University and School of Medicine, Baltimore, Maryland.

Design: Laboratory study.

Methods: ConjHA and unconjugated HA (unconjHA) at varied ratios were used to produce OVD (conjOVD) with varied fluorescence intensity. The conjHA:unconjHA ratio was optimized to maximize clarity under white light and fluorescence intensity under cobalt blue light (CBL), allowing for conditional visualization. The effect of conjugation on conjOVD viscosity was assessed by rotational rheometry. Intraocular lenses (IOLs) were immersed in conjOVD for 4 hours to assess staining of IOLs. A proof-of-concept study was performed in ex vivo porcine eyes. After injection and visualization, the OVDs were removed from the eyes by irrigation/aspiration (I/A).

Results: 0.5 mg/mL of conjHA (degree of substitution = 0.005) enabled robust fluorescence of conjOVD under CBL. Fluorescein conjugation did not significantly affect conjOVD viscosity ( P > .05 for mean difference in viscosity at all shear rates tested). No staining of IOLs was appreciated. ConjOVD was visualized under CBL when injected ex vivo and maintained clarity of the anterior chamber under white light. Importantly, conjHA enabled delineation of retained OVD after I/A.

Conclusions: Use of OVD composed of fluorescein-conjugated HA is a feasible method to enable conditional visualization of OVD intraoperatively without nonspecific staining of ocular structures. Further development of this technology may enable accelerated OVD removal in ocular surgery or decreased OVD retention postoperatively.

Topic: Topical nonsteroidal anti-inflammatory drugs (NSAIDs) for management of pain in patients after photorefractive keratectomy (PRK).

Clinical relevance: Pain after PRK is a major concern for both patients and surgeons. Although evidence supports the use of NSAIDs postoperatively, no consensus exists regarding the preferred regimen. The study aimed to compare the efficacy and safety of different topical NSAIDs.

Methods: This study was prospectively registered with PROSPERO (ID: CRD42023417651). A systematic search of electronic databases was performed, for randomized controlled trials reporting topical NSAIDs' outcomes of corneal re-epithelization, rescue analgesics intake, and pain in days 0 to 3 after PRK (postoperative days [PODs] 0 to 3). Studies were graded for risk of bias. Data were extracted, and standardized mean differences (SMDs) were evaluated in a network meta-analysis in accordance with the Cochrane's guidelines, to which a frequentist approach model was fitted. Transitivity was assessed using the net split method. Treatment effectiveness was ranked using forest plots based on comparison with placebo. P-scores (P) and league tables were used to examine combined direct and indirect comparisons.

Results: Of 1540 studies identified, 27 were included. These encompassed 2286 patients across 11 countries, evaluating 7 distinct topical NSAIDs. At POD0, ketorolac (P 0.764), flurbiprofen (P 0.763), and bromfenac (P 0.717) were the most efficient drugs overall and displayed significantly lower pain scores than placebo. Other than that, flurbiprofen held the highest rank for reported pain throughout, significantly outperforming placebo on POD1 (P 0.874, SMD -1.19, 95% CI -1.86 to -0.52), POD2 (P 0.882, SMD -1.05, 95% CI -1.82 to -0.27), and POD3 (P 0.939, SMD -1.14, 95% CI -2.1 to -0.18). Other NSAIDs were significantly better than placebo only on POD1 and POD0. Rescue analgesic intake analysis favored indomethacin (P 0.834, SMD -0.8, 95% CI -1.33 to -0.27), ketorolac, and diclofenac. Compared with placebo, re-epithelization was slowed to different significances with all NSAIDs but flurbiprofen (P 0.991, SMD -0.7, 95% CI -1.38 to -0.03).

Conclusions: Flurbiprofen was favorable in pain scores on typically painful postoperative days and re-epithelization times. However, analgesics intake, a more objective outcome, suggested superiority of other NSAIDs. Inconsistencies may be explained by the small sample size. For clinical interpretation, NSAID effect sizes should be taken into consideration.

Purpose: To investigate the changing patterns of corneal endothelial cells and the associated factors in children with congenital ectopia lentis (CEL) after scleral-fixated intraocular lens (SF IOL) surgery.

Setting: Zhongshan Ophthalmic Center, Guangzhou, China.

Design: Retrospective study.

Methods: Patients were divided into the surgery group and the control group. Central endothelial cell density (ECD), coefficient of variation in cell size, the percentage of hexagonal cells (hexagonality), average cell size (AVG), and central corneal thickness were analyzed for both groups at baseline and each follow-up visit. Clinic characteristic, ocular parameters, IOL decentration, and IOL tilt of patients in the surgery group were collected. Multiple linear regression was performed to assess the potential associated factors for the postoperative changes in corneal endothelial cells in the surgery group.

Results: After 2-year follow-up, the decline of ECD was 17.8% (95% CI, -21.8 to -13.9) in the surgery group and -3.1% (95% CI, -5.2 to -1.0) in the control group ( P < .001), while the increase of AVG was 24.3% (17.1-31.6) in the surgery group and 2.7% (1.0 to 4.5) in the control group ( P < .001). Multivariate analysis showed that axial length (AL) ≥24 mm and white-to-white (WTW) <12.2 mm were significantly associated with greater loss of ECD (β = -241.41, 95% CI, -457.91 to -24.91, P = .030 and β = 251.63, 95% CI, 42.10-461.17, P = .020, respectively) and AL ≥24 mm was significantly positively associated with the increase of AVG (β = 34.81, 95% CI, 0.90-68.71, P = .044).

Conclusions: The SF IOL had a significant impact on corneal endothelium in children with CEL. More attention should be paid to monitor postoperative corneal endothelium change during long-term follow-up in CEL children, especially for those with longer AL and smaller WTW.

Purpose: To evaluate the stability of the postoperative vault of the implantable phakic contact lens (IPCL) 5 years after implantation.

Setting: Clínica de Ojos Dr. Nano, Olivos, Buenos Aires, Argentina.

Design: Retrospective case-series study.

Methods: Myopic patients operated with the IPCL for spherical correction in which preoperative data were compared with different scenarios of postoperative vault at 1, 3, and 5 years postoperatively. The main parameter to be evaluated was the vault obtained 5 years postoperatively.

Results: 140 eyes of 72 patients, aged 31.9 ± 2.8 years (21 to 50), were included. Most of the eyes (78.6%) obtained a vault between 250 μm and 750 μm, while in 15% of the eyes, it was less than 250 μm, and 6.4% were greater than 750 μm. The vault evaluated 1, 3, and 5 years postoperatively remained stable. Subcapsular cataracts were detected in 2 eyes, with vault <250 μm. A total of 50 eyes (35.7%) had cysts in the sulcus (5 cases in the group of eyes with vault >750 μm). No changes were detected in relation to intraocular pressure or endothelial cell count.

Conclusions: In eyes implanted with the IPCL over 5 years, it was observed that the vault remained stable over time. The proportion of eyes with cysts was higher in eyes with vaults larger than 750 μm.

Purpose: To compare the rotational stability and visual outcomes of plate-haptic toric intraocular lenses (IOLs) with and without a capsular tension ring (CTR) in paired eyes.

Setting: Eye and Ears, Nose, and Throat Hospital of Fudan University, Shanghai, China.

Design: Prospective, randomized, paired-eye study.

Methods: Patients with bilateral cataracts and coexisting regular corneal astigmatism were enrolled. The two eyes of each patient were randomly assigned to the CTR or non-CTR (NCTR) group. Both eyes of each patient were subjected to phacoemulsification and toric IOL implantation. CTRs were implanted into the eyes of the CTR group. All patients were followed-up for 12 months; the uncorrected distance visual acuity (UDVA), residual astigmatism (RAS), and rotational degree of the toric IOL were recorded.

Results: In total, 186 eyes of 93 patients were eligible for analysis. At each visit, UDVA improved significantly after surgery in all eyes (p < 0.001). The mean rotational degree and RAS were significantly smaller in the CTR group at the 2-week visit (p < 0.05). The toric IOLs achieved rotational stability at 1 week postoperatively in the CTR group while at 2 weeks postoperatively in the NCTR group. In the subgroup analyses, CTR co-implantation significantly reduced the 2-week IOL rotation in eyes meeting specific ocular measurements.

Conclusions: CTR co-implantation could increase the rotational stability of plate-haptic toric IOLs, by reducing the amount of the IOL rotation in the early postoperative period and accelerating the stabilization of IOLs in the capsular bag.

Topic: To systematically compare the effectiveness of conventional phacoemulsification surgery (CPS) and low-energy femtosecond laser-assisted cataract surgery (FLACS) in patients with cataract.

Clinical relevance: Cataract surgery is a common procedure, and comparing different techniques such as CPS and low-energy FLACS is crucial for optimizing patient outcomes.

Methods: The PubMed, Web of Science, MEDLINE, EMBASE, and Cochrane library databases were searched for clinical trials. Outcomes of procedure time, effective phacoemulsification time, balanced salt solution usage, cumulative dissipated energy, mean change of corrected distance visual acuity, endothelial cells reduction, central corneal thickness (CCT), and aqueous cytokine level were evaluated. The effect measures were weighted mean differences with 95% CI. The protocol was registered at the Prospective Register for Systematic Reviews (registration number CRD42023420173).

Results: 11 studies were included in this meta-analysis, of which 1680 eyes were analyzed (637 eyes in the low-energy FLACS group and 1043 eyes in the CPS group). Low-energy FLACS demonstrated significantly fewer reductions in endothelial cell count at 6 months ( P < .001) compared with CPS. It also exhibited a shorter effective phacoemulsification time ( P < .001) and less balanced salt solution usage ( P < .001). However, there were no differences in cumulative dissipated energy, corrected distance visual acuity, CCT changes, or aqueous cytokine levels between the 2 groups.

Conclusions: Both low-energy FLACS and CPS are effective in treating cataracts, but low-energy FLACS may offer advantages such as reduced phacoemulsification time and less endothelial cell loss.

Purpose: To investigate the factors affecting footplate position and its influence on vault characteristics after implantable collamer lens (ICL) implantation.

Setting: Hunan Provincial People's Hospital, Changsha, China.

Design: Retrospective case series.

Methods: This study included 124 patients (124 eyes). Ultrasound biomicroscopy (UBM) was performed to assess the iris and ciliary body morphologies and observe the footplate position. Using multiple linear regression, the relationship between various ocular and ICL parameters and the vault as well as the factors affecting the footplate distance (FD) were analyzed. Based on the FD, 3 groups were formed: group 1 (<500 μm), group 2 (500 to 1000 μm), and group 3 (>1000 μm). The distribution of the vault range postoperatively was observed for the 3 groups.

Results: Ciliary sulcus angle and FD significantly affected the vault (adjusted R2 = 0.190, F = 6.763, P < .001), with FD being the most important factor influencing the vault (β = -0.383, P < .001). Postoperative UBM revealed that the footplate was located at different positions in the posterior chamber, with the majority (52%) being located on the ciliary body. The mean size of the 4 footplate orientations was 0.88 ± 0.24 mm. Multiple linear regression analysis revealed that ciliary body thickness (CBT), iris curvature (IC), and ICL iris contact length (IRCL) significantly influenced the FD (adjusted R2 = 0.373, F = 11.432, P < .001). The vault range differed significantly among the 3 groups (X 2 = 32.33, P < .001).

Conclusions: Different postoperative ICL footplate positions significantly affect the vault. CBT, IC, and IRCL can alter the position of the footplate from the expected position. This study provides reference for ICL size selection and vault prediction.