Correcting Finger Counting to Snellen Acuity

Karanjia, Rustum; Hwang, Tiffany; Chen, Alexander Francis; Pouw, Andrew; Tian, Jun-Ru; Chu, Edward; Wang, Michelle; Tran, Justin; Sadun, Alfredo A.

doi:10.1080/01658107.2016.1209221

Cited by 11 publications

(5 citation statements)

References 4 publications

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“…When subjects could not read any letters on the ETDRS chart, they were asked to count the assessor's fingers or to detect hand motion. An off-chart Snellen equivalent was derived using both the distance at which the assessment was made and the size of the assessor's fingers, as described by Karanjia et al (43) The standardized automated HVF 30-2, Central Threshold, SITA-FAST procedure was performed with the HVF Analyzer II. The reliability of the HVF test results were quality controlled by the ONRC reading center and the HVF test was repeated if considered unreliable by that center (defined as fixation losses ≥ 15%, false positive errors ≥ 20%, or false negative errors ≥ 33%).…”

Section: Outcome Measuresmentioning

confidence: 99%

Section: Outcome Measuresmentioning

confidence: 99%

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Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy

et al. 2020

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REVERSE is a randomized, double-masked, sham-controlled, multicenter, phase 3 clinical trial that evaluated the efficacy of a single intravitreal injection of rAAV2/2-ND4 in subjects with visual loss from Leber hereditary optic neuropathy (LHON). A total of 37 subjects carrying the m.11778G>A (MT-ND4) mutation and with duration of vision loss between 6 to 12 months were treated. Each subject’s right eye was randomly assigned in a 1:1 ratio to treatment with rAAV2/2-ND4 (GS010) or sham injection. The left eye received the treatment not allocated to the right eye. Unexpectedly, sustained visual improvement was observed in both eyes over the 96-week follow-up period. At week 96, rAAV2/2-ND4–treated eyes showed a mean improvement in best-corrected visual acuity (BCVA) of −0.308 LogMAR (+15 ETDRS letters). A mean improvement of −0.259 LogMAR (+13 ETDRS letters) was observed in the sham-treated eyes. Consequently, the primary end point, defined as the difference in the change in BCVA from baseline to week 48 between the two treatment groups, was not met (P = 0.894). At week 96, 25 subjects (68%) had a clinically relevant recovery in BCVA from baseline in at least one eye, and 29 subjects (78%) had an improvement in vision in both eyes. A nonhuman primate study was conducted to investigate this bilateral improvement. Evidence of transfer of viral vector DNA from the injected eye to the anterior segment, retina, and optic nerve of the contralateral noninjected eye supports a plausible mechanistic explanation for the unexpected bilateral improvement in visual function after unilateral injection.

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Section: Outcome Measuresmentioning

confidence: 99%

Section: Outcome Measuresmentioning

confidence: 99%

Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy

et al. 2020

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“…An off-chart Snellen equivalent was derived using both the distance at which the assessment was made and the size of the assessor's fingers. 20 The method was also adapted to hand motion visual acuity to provide conversion into a logMAR value. Light perception and no light perception visual acuities were assigned a value of 4.0 and 4.5 logMAR, respectively.…”

Section: Outcome Measuresmentioning

confidence: 99%

Efficacy and Safety of Intravitreal Gene Therapy for Leber Hereditary Optic Neuropathy Treated within 6 Months of Disease Onset

et al. 2021

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Purpose: To evaluate the efficacy of a single intravitreal injection of rAAV2/2-ND4 in subjects with visual loss from Leber hereditary optic neuropathy (LHON).Design: RESCUE is a multicenter, randomized, double-masked, sham-controlled, phase 3 clinical trial.Participants: Subjects with the m.11778G>A mitochondrial DNA mutation and vision loss 6 months from onset in 1 or both eyes were included.Methods: Each subject's right eye was randomly assigned (1:1) to treatment with rAAV2/2-ND4 (single injection of 9 Â 10 10 viral genomes in 90 ml) or to sham injection. The left eye received the treatment not allocated to the right eye. Main Outcome Measures: The primary end point was the difference of the change from baseline in bestcorrected visual acuity (BCVA) between rAAV2/2-ND4etreated and sham-treated eyes at week 48. Other outcome measures included contrast sensitivity, Humphrey visual field perimetry, retinal anatomic measures, and quality of life. Follow-up extended to week 96.Results: Efficacy analysis included 38 subjects. Mean age was 36.8 years, and 82% were male. Mean duration of vision loss at time of treatment was 3.6 months and 3.9 months in the rAAV2/2-ND4etreated eyes and sham-treated eyes, respectively. Mean baseline logarithm of the minimum angle of resolution (logMAR) BCVA (standard deviation) was 1.31 (0.52) in rAAV2/2-ND4etreated eyes and 1.26 (0.62) in sham-treated eyes, with a range from À0.20 to 2.51. At week 48, the difference of the change in BCVA from baseline between rAAV2/2-ND4etreated and sham-treated eyes was À0.01 logMAR (P ¼ 0.89); the primary end point of a À0.3 logMAR (15-letter) difference was not met. The mean BCVA for both groups deteriorated over the initial weeks, reaching the worst levels at week 24, followed by a plateau phase until week 48, and then an improvement of þ10 and þ9 Early Treatment Diabetic Retinopathy Study letters equivalent from the plateau level in the rAAV2/2-ND4etreated and sham-treated eyes, respectively.Conclusions: At 96 weeks after unilateral injection of rAAV2/2-ND4, LHON subjects carrying the m.11778G>A mutation treated within 6 months after vision loss achieved comparable visual outcomes in the injected and uninjected eyes.

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“…When subjects could not read any letters on the ETDRS chart, they were asked to count the assessor's fingers or to detect hand motion. An off-chart Snellen equivalent was derived using both the distance at which the assessment was made and the size of the assessor's fingers, as described by Karanjia et al ( 18 ) (this method was also adapted to hand motion visual acuity), then was converted into a LogMAR value. Light perception and no light perception visual acuities were assigned a value of 4.0 and 4.5 LogMAR, respectively.…”

Section: Methodsmentioning

confidence: 99%

Cross-Sectional Analysis of Baseline Visual Parameters in Subjects Recruited Into the RESCUE and REVERSE ND4-LHON Gene Therapy Studies

Moster

Sergott

Newman

et al. 2021

Journal of Neuro-Ophthalmology

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Objective: This report presents a cross-sectional analysis of the baseline characteristics of subjects with Leber hereditary optic neuropathy enrolled in the gene therapy trials RESCUE and REVERSE, to illustrate the evolution of visual parameters over the first year after vision loss. Methods: RESCUE and REVERSE were 2 phase III clinical trials designed to assess the efficacy of rAAV2/2- ND4 gene therapy in ND4 -LHON subjects. At enrollment, subjects had vision loss for ≤6 months in RESCUE, and between 6 and 12 months in REVERSE. Functional visual parameters (best-corrected visual acuity [BCVA], contrast sensitivity [CS], and Humphrey Visual Field [HVF]) and structural parameters assessed by spectral-domain optical coherence tomography were analyzed in both cohorts before treatment. The cross-sectional analysis of functional and anatomic parameters included the baseline values collected in all eyes at 2 different visits (Screening and Inclusion). Results: Seventy-six subjects were included in total, 39 in RESCUE and 37 in REVERSE. Mean BCVA was significantly worse in RESCUE subjects compared with REVERSE subjects (1.29 and 1.61 LogMAR respectively, P = 0.0029). Similarly, mean CS and HVF were significantly more impaired in REVERSE vs RESCUE subjects ( P < 0.005). The cross-sectional analysis showed that the monthly decrease in BCVA, ganglion cell layer macular volume, and retinal nerve fiber layer thickness was much more pronounced in the first 6 months after onset (+0.24 LogMAR, −0.06 mm 3 , and −6.00 μm respectively) than between 6 and 12 months after onset (+0.02 LogMAR, −0.01 mm 3 , and −0.43 μm respectively). Conclusion: LHON progresses rapidly in the first months following onset during the subacute phase, followed by relative stabilization during the dynamic phase.

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Correcting Finger Counting to Snellen Acuity

Cited by 11 publications

References 4 publications

Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy

Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy

Efficacy and Safety of Intravitreal Gene Therapy for Leber Hereditary Optic Neuropathy Treated within 6 Months of Disease Onset

Cross-Sectional Analysis of Baseline Visual Parameters in Subjects Recruited Into the RESCUE and REVERSE ND4-LHON Gene Therapy Studies

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