Efficacy, Safety and Immunogenicity of Sun's Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study.

INTRODUCTION: The study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun's ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). METHODS: This prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50 years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5 mg (0.05 mL) intravitreal injection of either Sun's ranibizumab or reference ranibizumab in the study eye every 4 weeks until week 16 (total of four doses). RESULTS: Primary endpoint results demonstrated equivalence in the proportion of patients who lost fewer than 15 letters from baseline best-corrected visual acuity (BCVA) to the end of week 16 (99% of patients in Sun's ranibizumab and 100% in reference ranibizumab; p > 0.9999), with the proportional difference (90% confidence interval) at -1% (-2.51, +0.61) lying within a pre-specified equivalence margin. Visual acuity improved by 15 or more letters in 43% of Sun's ranibizumab group and 37% of the reference ranibizumab group (p = 0.4267). The mean increase in BCVA was 15.7 letters in Sun's ranibizumab group and 14.6 letters in the reference ranibizumab group (p < 0.001 within both groups and p = 0.5275 between groups). The mean change in central macular thickness was comparable between groups (p = 0.7946). Anti-ranibizumab antibodies were found in one patient of the reference ranibizumab group, while neutralising antibodies were not found in any patients. Both products were well tolerated. CONCLUSION: Sun's ranibizumab biosimilar is found to be therapeutically equivalent to reference ranibizumab in patients with nAMD. There were no additional safety or immunogenicity concerns. TRIAL REGISTRATION: CTRI/2020/09/027629, registered on 07 September 2020.

Natural course of non-center-involving diabetic macular edema progression in patients under initial observation.

PURPOSE: We aim to report the natural course of non-center involving diabetic macular edema (NCIDME) progression to center involving diabetic macular edema (CIDME) and associated risk factors. METHODS: This is a multicenter retrospective comparative study. Data was collected from electronic medical records from 8 centers in India covering. We included patients with type 2 diabetes above 18 years of age with treatment-naïve NCIDME on OCT and best-corrected visual acuity at baseline of 6/12 or better who were under observation for NCIDME and had 2 years follow-up data. RESULTS: Out of 72 patients with NCIDME, 26.38% patients progressed to CI DME by 2 years, and the visit wise proportion was 11.11% at 6 months, 7% at 1st year and 8.3% at 2 years. The change in CST was statistically significant at 2 years in patients who developed CIDME, the mean difference was 137.73 ± 48.56 microns p = 0.045. Duration of diabetes mellitus > 10 years was the only risk factor for conversion to CIDME. CONCLUSION: A quarter of eyes with NCIDME developed CIDME and 15% progressed from NPDR to PDR by 2 years, highlighting the disease burden in these patients with NCIDME.

Comparative proteomics of proliferative diabetic retinopathy in people with Type 2 diabetes highlights the role of inflammation, visual transduction, and extracellular matrix pathways.

Purpose: To explore the vitreous humor proteome from type 2 diabetes subjects with proliferative diabetic retinopathy (PDR) in the Indian population. Methods: We performed mass spectrometry-based label-free quantitative analysis of vitreous proteome of PDR (n = 13) and idiopathic macular hole (IMH; control) subjects (n = 14). Nine samples of PDR and 10 samples of IMH were pooled as case and control, respectively, and compared. Four samples each of PDR and IMH were analyzed individually without pooling to validate the results of the pooled analysis. Comparative quantification was performed using Scaffold software which calculated the fold changes of differential expression. Bioinformatics analysis was performed using DAVID and STRING software. Results: We identified 469 proteins in PDR and 517 proteins in IMH vitreous, with an overlap of 172 proteins. Also, 297 unique proteins were identified in PDR and 345 in IMH. In PDR vitreous, 37 proteins were upregulated (P < 0.05) and 19 proteins were downregulated compared to IMH. Protein distribution analysis clearly demonstrated a separation of protein expression in PDR and IMH. Significantly upregulated proteins included fibrinogen gamma chain, fibrinogen beta chain, and carbonic anhydrase 1 and downregulated proteins included alpha-1-antitrypsin, retinol-binding protein 3, neuroserpin, cystatin C, carboxypeptidase E and cathepsin-D. Conclusion: Diabetic retinopathy pathogenesis involves proteins which belong to inflammation, visual transduction, and extracellular matrix pathways. Validation-based experiments using enzyme-linked immunosorbent assay (ELISA) or western blotting are needed to establish cause and effect relationships of these proteins to the disease state, to develop them as biomarkers or drug molecules.

A study establishing sensitivity and accuracy of smartphone photography in ophthalmologic community outreach programs: Review of a smart eye camera.

Purpose: Diseases affecting the cornea are a major cause of corneal blindness globally. The pressing issue we are facing today is the lack of diagnostic devices in rural areas to diagnose these conditions. The aim of the study is to establish sensitivity and accuracy of smartphone photography using a smart eye camera (SEC) in ophthalmologic community outreach programs. Methods: In this pilot study, a prospective non-randomized comparative analysis of inter-observer variability of anterior segment imaging recorded using an SEC was performed. Consecutive 100 patients with corneal pathologies, who visited the cornea specialty outpatient clinic, were enrolled. They were examined with a conventional non-portable slit lamp by a cornea consultant, and the diagnoses were recorded. This was compared with the diagnoses made by two other consultants based on SEC videos of the anterior segment of the same 100 patients. The accuracy of SEC was accessed using sensitivity, specificity, PPV, and NPV. Kappa statistics was used to find the agreement between two consultants by using STATA 17.0 (Texas, USA). Results: There was agreement between the two consultants to diagnosing by using SEC. Above 90% agreements were found in all the diagnoses, which were statistically significant (P-value < 0.001). More than 90% sensitivity and a negative predictive value were found. Conclusion: SEC can be used successfully in the community outreach programs like field visits, eye camps, teleophthalmology, and community centers, where either a clinical setup is lacking or ophthalmologists are not available.

Unilateral retinitis pigmentosa associated with cystoid macular oedema.

Retinitis pigmentosa (RP) is the most common inherited cause of blindness in the developed world, characterized by night blindness, reduced central vision and constricted visual field; however, unilateral RP is extremely rare. Macular complications such as cystoid macular oedema (CME), macular holes and vitreoretinal interface alterations, such as epiretinal membranes, have been reported in advanced stages. We describe a patient with unilateral RP presenting with CME, a rare occurrence.

Correlating the patterns of diabetic macular edema, optical coherence tomography biomarkers and grade of diabetic retinopathy with stage of renal disease.

PURPOSE: To correlate optical coherence tomography (OCT)-based morphological patterns of diabetic macular edema (DME), biomarkers and grade of diabetic retinopathy (DR) in patients with various stages of chronic kidney disease (CKD) secondary to diabetes. DESIGN: Multicentric retrospective cross-sectional study was conducted at seven centers across India. METHODS: Data from medical records of patients with DME and CKD were entered in a common excel sheet across all seven centers. Staging of CKD was based on estimated glomerular filtration rate (eGFR). RESULTS: The most common morphological pattern of DME was cystoid pattern (42%) followed by the mixed pattern (31%). The proportion of different morphological patterns did not significantly vary across various CKD stages (p = 0.836). The presence of external limiting membrane-ellipsoid zone (ELM-EZ) defects (p < 0.001) and foveal sub-field thickness (p = 0.024) showed a direct correlation with the stage of CKD which was statistically significant. The presence of hyperreflective dots (HRD) and disorganization of inner retinal layers (DRIL) showed no significant correlation with the stage of CKD. Sight threatening DR was found to increase from 70% in CKD stage 3 to 82% in stages 4 and 5 of CKD, and this was statistically significant (p = 0.03). CONCLUSION: Cystoid morphological pattern followed by mixed type was the most common pattern of DME on OCT found in patients suffering from stage 3 to 5 of CKD. However, the morphological patterns of DME did not significantly vary across various CKD stages. ELM-EZ defects may be considered as an important OCT biomarker for advanced stage of CKD.

Multicenter Evaluation of Diagnostic Circulating Biomarkers to Detect Sight-Threatening Diabetic Retinopathy.

Importance: It is a global challenge to provide regular retinal screening for all people with diabetes to detect sight-threatening diabetic retinopathy (STDR). Objective: To determine if circulating biomarkers could be used to prioritize people with type 2 diabetes for retinal screening to detect STDR. Design, Setting, and Participants: This cross-sectional study collected data from October 22, 2018, to December 31, 2021. All laboratory staff were masked to the clinical diagnosis, assigned a study cohort, and provided with the database containing the clinical data. This was a multicenter study conducted in parallel in 3 outpatient ophthalmology clinics in the UK and 2 centers in India. Adults 40 years and older were categorized into 4 groups: (1) no history of diabetes, (2) type 2 diabetes of at least 5 years' duration with no evidence of DR, (3) nonproliferative DR with diabetic macular edema (DME), or (4) proliferative DR. STDR comprised groups 3 and 4. Exposures: Thirteen previously verified biomarkers were measured using enzyme-linked immunosorbent assay. Main Outcomes and Measures: Severity of DR and presence of DME were diagnosed using fundus photographs and optical coherence tomography. Weighted logistic regression and receiver operating characteristic curve analysis (ROC) were performed to identify biomarkers that discriminate STDR from no DR beyond the standard clinical parameters of age, disease duration, ethnicity (in the UK) and hemoglobin A1c. Results: A total of 538 participants (mean [SD] age, 60.8 [9.8] years; 319 men [59.3%]) were recruited into the study. A total of 264 participants (49.1%) were from India (group 1, 54 [20.5%]; group 2, 53 [20.1%]; group 3, 52 [19.7%]; group 4, 105 [39.8%]), and 274 participants (50.9%) were from the UK (group 1, 50 [18.2%]; group 2, 70 [25.5%]; group 3, 55 [20.1%]; group 4, 99 [36.1%]). ROC analysis (no DR vs STDR) showed that in addition to age, disease duration, ethnicity (in the UK) and hemoglobin A1c, inclusion of cystatin C had near-acceptable discrimination power in both countries (area under the receiver operating characteristic curve [AUC], 0.779; 95% CI, 0.700-0.857 in 215 patients in the UK with complete data; AUC, 0.696; 95% CI, 0.602-0.791 in 208 patients in India with complete data). Conclusions and Relevance: Results of this cross-sectional study suggest that serum cystatin C had good discrimination power in the UK and India. Circulating cystatin-C levels may be considered as a test to identify those who require prioritization for retinal screening for STDR.

Is perioperative blood pressure monitoring during intravitreal injections important?

Background: Anti-vascular endothelial growth factor intravitreal injections (IVIs) have proved to be a boon for patients suffering from several retinal pathologies. They are one of the most commonly performed procedures in ophthalmology. A perioperative rise in blood pressure (BP) has been noted during cataract surgery. Objectives: To evaluate the perioperative BP changes during IVI, and the associated risk factors. Design: Cross-sectional observational study. Methods: The patients undergoing IVI from May 2019 to August 2019 were evaluated. All the patients underwent BP measurement before, during, and 1 h after the IVI. The correlation between the demographics and, the systemic comorbidities of the patients, and the ocular condition for which IVI was given was evaluated. Results: The study included 302 patients (mean age of 59.9 ± 10.7 years). The mean increase in systolic BP (SBP) and diastolic BP (DBP) at the time of injection was 25.7 ± 21.0 and 1.3 ± 13.4 mmHg, respectively. A ⩾ 10, ⩾ 20, ⩾ 30 mmHg increase in SBP at the time of injection was seen in 83.8% (n = 253), 69.5% (n = 210) and 49.0% (n = 148) patients, respectively. Forty-one (13.6%) patients developed intra-procedural hypertensive urgency, out of which six patients (14.6%) did not recover even after 1 h of the procedure. None of the patients experienced any cardiovascular events. The univariate and multivariate linear regression analyses showed that the change in intra-procedural SBP correlated positively with the age of the patient and negatively with the baseline SBP. Conclusion: There is a significant rise of SBP at the time of IVI, especially in patients with advanced age and high baseline SBP. Some of the patients can experience hypertensive urgency at the time of injection and may take more than 1 h to recover. The patients receiving IVI should undergo a detailed physician evaluation before the procedure.

Retinal detachment in eyes treated with Aurolab aqueous drainage implant for refractory glaucoma - Incidence and outcomes.

Purpose: To analyze the incidence of rhegmatogenous retinal detachment (RRD) in patients who have undergone prior Aurolab aqueous drainage implant (AADI) surgery and report outcomes in terms of anatomic, visual acuity, and intraocular pressure (IOP) findings. Methods: Case records of all patients who underwent RRD repair after AADI surgery from 2013 to 2019 were retrospectively analyzed. Data collected included patient demographics, ocular examination findings at all visits including IOP and best-corrected visual acuity (BCVA) and clinical findings related to RRD both at baseline and postoperatively. Results: Ten eyes of nine patients were included in study. The mean age of patients was 28.2 years (median: 15 years, range: 6-83 years). Mean duration between AADI and RRD was 14 months (median 2.5 months; range 2 days-72 months). All eyes underwent pars plana vitrectomy with silicon oil injection. The preoperative LogMAR BCVA (logarithm of the minimum angle of resolution) was 2.52 ± 0.15 which improved to 2.29 ± 0.58 at final follow-up; however, only one eye had vision ≥ 20/400 largely due to recurrent RRD and advanced glaucomatous disc damage. Postoperatively retina was attached in 6 eyes (60%) and IOP was ≤ 21 mmHg in 5 out of 6 eyes with anatomic success. Conclusion: The incidence of RRD following AADI was found to be 0.86% in our study. Pars plana vitrectomy (PPV) with silicon oil tamponade was the preferred approach in the management of these eyes with IOP being well controlled post PPV. However, visual acuity outcomes were largely unsatisfactory due to recurrent RRD and preexisting advanced glaucoma.

Digitally assisted vitreoretinal surgery: A unique surgical teaching tool for beginners.

PURPOSE: To study the role of digitally assisted vitreoretinal surgery (DAVS) as a learning and teaching tool compared to that of the standard binocular side-scope of the conventional analog microscope (CAM). METHODS: This was a cross-sectional, observational study conducted at a tertiary eye care center and teaching institute in South India. Postgraduate residents and clinical fellows observed a predecided set of retinal surgical procedures using both DAVS and CAM. A detailed questionnaire was used to compare the participants' subjective scoring of both the platforms in terms of level of comfort, clarity of image and stereopsis, level of understanding, and overall impression. RESULTS: Thirty-six participants, including 20 residents and 16 fellows, took part in this study. DAVS obtained a higher score for all 15 questions compared to CAM and the differences were statistically significant. DAVS obtained a mean score of 4.80 (median: 5) whereas CAM obtained a mean score of 3.14 (median: 3) on a grading scale of 1-5 with regard to the overall experience of surgical viewing through either platform (P < 0.01). CONCLUSION: DAVS is a better learning and teaching tool compared to the side scope of the CAM from a learner's perspective. Thus, DAVS can help beginners in the field of vitreoretinal surgery obtain a better understanding of the surgical steps prior to the initiation of hands-on training.

Ochrobactrum anthropi: A Rare Cause of Culture-Proven Acute Post-Operative Cluster Endophthalmitis.

AIM: To report the clinical presentation and management outcomes of an outbreak of culture-proven post-operative endophthalmitis (POE) secondary to Ochrobactrum anthropi. METHODS: This study was conducted at a tertiary-care eye hospital in South India. RESULTS: Fifty-five patients underwent cataract surgery by six surgeons on three consecutive days in the same surgical facility in September 2020. Four patients developed POE after a mean interval of 12.0 ± 4.8 days and underwent immediate vitreous tap and intravitreal antibiotic injections (Vancomycin and Ceftazidime). All patients required a core vitrectomy (culture positive, n = 4/4). Two patients underwent an additional intraocular lens explantation, 2 and 4 months after presentation. All the four patients showed good anatomical and functional recoveries (mean follow-up, 5.75 ± 1.5 months). Two other patients had an exaggerated post-operative inflammation, which was successfully treated with topical medications. CONCLUSIONS: O. anthropi is a rare cause of acute POE. Although the isolated organism was multi-drug resistant, the outcome was good in all the patients.

Challenges in Post-cataract Surgery Nocardia Endophthalmitis: Management Strategies and Clinical Outcomes.

PURPOSE: To describe the clinical and microbiological features, management strategies, outcomes, and challenges in post-cataract surgery nocardia endophthalmitis. METHODS: We evaluated 28 eyes with culture-confirmed Nocardia endophthalmitis following cataract surgery. Data were collected regarding age, gender, clinical presentation, management modalities used, and final outcomes. RESULTS: Mean age of the patients was 66.07 + -8.6 years. Four eyes (14.3%) underwent early pars plana core vitrectomy, while 18 eyes (64.3%) underwent tap/inject regimen followed by observation for 48 h, with or without a delayed vitrectomy. Thirteen eyes (46.4%) received amikacin treatment. Visual acuity (VA) improved from presentation in 9/28 (32.1%) eyes, worsened in 14/28 (50%) eyes, and showed no change in 5/28 eyes (17.9%). CONCLUSIONS: We did not find any significant association between functional outcome and time of surgery or presenting VA. Additional amikacin may be considered if there is a strong suspicion of nocardia endophthalmitis, as it may help in achieving better anatomical outcomes.

Using artificial intelligence for diabetic retinopathy screening: Policy implications.

Artificial intelligence (AI) has evolved over the last few years; its use in DR screening has been demonstrated in multiple evidences across the globe. However, there are concerns right from the data acquisition, bias in data, difficulty in comparing between different algorithm, challenges in machine learning, its application in different group of population, and human barrier to AI adoption in health care. There are also legal and ethical concerns related to AI. The tension between risks and concerns on one hand versus potential and opportunity on the other have driven a need for authorities to implement policies for AI in DR screening to address these issues. The policy makers should support and facilitate research and development of AI in healthcare, but at the same time, it has to be ensured that the use of AI in healthcare aligns with recognized standards of safety, efficacy, and equity. It is essential to ensure that algorithms, datasets, and decisions are auditable and when applied to medical care (such as screening, diagnosis, or treatment) are clinically validated and explainable. Policy frameworks should require design of AI systems in health care that are informed by real-world workflow and human-centric design. Lastly, it should be ensured that healthcare AI solutions align with all relevant ethical obligations, from design to development to use and to be delivered properly in the real world.

Telemedicine in diabetic retinopathy screening in India.

With ever-growing prevalence of diabetes mellitus and its most common microvascular complication diabetic retinopathy (DR) in Indian population, screening for DR early for prevention of development of vision-threatening stages of the disease is becoming increasingly important. Most of the programs in India for DR screening are opportunistic and a universal screening program does not exist. Globally, telemedicine programs have demonstrated accuracy in classification of DR into referable disease, as well as into stages, with accuracies reaching that of human graders, in a cost-effective manner and with sufficient patient satisfaction. In this major review, we have summarized the global experience of telemedicine in DR screening and the way ahead toward planning a national integrated DR screening program based on telemedicine.

The ORNATE India project: Building research capacity and capability to tackle the burden of diabetic retinopathy-related blindness in India.

The ORNATE India project is an interdisciplinary, multifaceted United Kingdom (UK)-India collaborative study aimed to build research capacity and capability in India and the UK to tackle the burden of diabetes-related visual impairment. For 51 months (October 2017-December 2021), this project built collaboration between six institutions in the UK and seven in India, including the Government of Kerala. Diabetic retinopathy (DR) screening models were evaluated in the public system in Kerala. An epidemiological study of diabetes and its complications was conducted through 20 centers across India covering 10 states and one union territory. The statistical analysis is not yet complete. In the UK, risk models for diabetes and its complications and artificial intelligence-aided tools are being developed. These were complemented by joint studies on various aspects of diabetes between collaborators in the UK and India. This interdisciplinary team enabled increased capability in several workstreams, resulting in an increased number of publications, development of cost-effective risk models, algorithms for risk-based screening, and policy for state-wide implementation of sustainable DR screening and treatment programs in primary care in Kerala. The increase in research capacity included multiple disciplines from field workers, administrators, project managers, project leads, screeners, graders, optometrists, nurses, general practitioners, and research associates in various disciplines. Cross-fertilization of these disciplines enabled the development of several collaborations external to this project. This collaborative project has made a significant impact on research capacity development in both India and the UK.

Diabetic macular edema treatment guidelines in India: All India Ophthalmological Society Diabetic Retinopathy Task Force and Vitreoretinal Society of India consensus statement.

Diabetic macular edema (DME) is a common cause of moderate visual impairment among people with diabetes. Due to the rising number of people with diabetes in India, the absolute numbers of people with DME are significant. There are several treatment options for DME, and the choice of treatment is based on the availability of retinal specialists and infrastructure for the delivery of treatment. A major challenge is the out-of-pocket expenditure incurred by patients as most treatment options are costly. Treatment also varies based on the associated ocular and systemic conditions. The All India Ophthalmology Society (AIOS) and the Vitreo-Retinal Society of India (VRSI) have developed this consensus statement of the AIOS DR task force and VRSI on practice points of DME management in India. The objective is to describe the preferred practice patterns for the management of DME considering the different presentations of DME in different clinical scenarios.

Severity of diabetic retinopathy and its relationship with age at onset of diabetes mellitus in India: A multicentric study.

PURPOSE: To present clinical profile and risk factors of sight-threatening diabetic retinopathy (STDR) among people with age of onset of diabetes (AOD) <25 versus ≥25 years. METHODS: A retrospective chart analysis of consecutive patients with diabetic retinopathy (DR) n = 654) treated at 14 eye care centers across India between 2018 and 2019 was performed. Patients were divided into two groups, Group 1: AOD <25 years and Group 2: AOD ≥25 years. DR and diabetic macular edema (DME) were classified using the International Clinical Classification of DR severity scale. STDR included severe nonproliferative DR (NPDR), proliferative DR (PDR), and moderate to severe DME. A multilevel mixed-effects model was used for comparison between two groups: 1) Patients with DR and AOD <25 years and 2) Patients with DR and AOD ≥25 years. Bivariate and multivariate regression analyses were used to evaluate risk factors between the two groups. RESULTS: A total of 654 patients were included, 161 (307 eyes) in AOD <25 and 493 (927 eyes) in AOD >25 group. There was a higher prevalence of PDR with high-risk characteristics in AOD <25 group (24% vs. 12%) at baseline and 12-month follow-up (25% vs. 6%); P < 0.001. Systolic hypertension and poor glycemic control were risk factors in both groups, with no difference in these modifiable risk factors between groups. CONCLUSION: People with youth-onset DM are likely to present with severer form of STDR despite similar modifiable risk factors. Therefore, strict control of systolic blood pressure, glycemic status, and regular screening for DR are recommended to reduce the risk of STDR irrespective of the age of onset of diabetes.

Surgical outcome of full-thickness macular hole secondary to tractional retinal detachment in proliferative diabetic retinopathy.

PURPOSE: To evaluate the surgical outcome of full-thickness macular hole (FTMH) secondary to active fibrovascular proliferation (FVP) and tractional retinal detachment (TRD) in eyes with proliferative diabetic retinopathy (PDR), and factors influencing the outcome. METHODS: This retrospective study included the patients who underwent vitrectomy for FTMH secondary to PDR TRD from 2016 to 2020. Anatomical and visual outcomes were analyzed after six months along with the factors predicting the final outcome and duration of subretinal fluid (SRF) resolution. RESULTS: Group A (macula-off combined RD, i.e., tractional and rhegmatogenous) included 10 eyes, while group B (macula-threatening TRD) included eight eyes. The mean best-corrected visual acuity improved from logMAR 1.21 (Snellen equivalent: 20/324) to logMAR 0.76 (Snellen equivalent: 20/115) (P = 0.008). Seventeen patients gained ≥1 line(s) of vision. Mean visual gain in groups A and B was 3.7 ± 1.9 and 1.9 ± 1.1 lines, respectively (P = 0.051). MH closed in 88.9% eyes. Type 1 anatomical closure was achieved in 88.9% of eyes. At 6 months, SRF and central macular thickness reduced from 479.6 ± 512.5 µm to 11.4 ± 23.5 µm (P = 0.002) and 874.3 ± 422.6 µm to 207.6 ± 81.7 µm (P = 0.0002), respectively. Finally, macular SRF resolved in all the patients. The mean duration for complete SRF resolution was 4.9 ± 3.2 months. Eyes with a shorter duration of diabetes mellitus (rho = -0.49, P = 0.040) and macula-off combined RD (P = 0.048) took a longer time for complete SRF resolution. CONCLUSION: Good anatomical and visual outcomes can be achieved in eyes with PDR TRD-associated FTMH. The residual macular SRF resolves slowly after the surgery and extra intervention is not required. Macula-off combined RD is associated with worse outcome and a slower SRF resolution rate.