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In Brief | Opthalmology

Non-invasive pharmacological treatment shows promise in improving vision for early-stage cataract patients

Time to read: 02:19

Published on MedED: 4 October 2024

Originally Published: 2 August 2024
Sourced: American Journal of Ophthalmology
Type of article: In Brief
MedED Catalogue Reference: MOIB011
Category: Ophthalmology
Cross Reference: Gerontology, 
Keywords: cataracts, ophthalmic surgery, ophthalmic solution
 
Key Takeaway
This study demonstrated that 2.6% EDTA ophthalmic solution (C-KAD) improved contrast sensitivity in patients with early-stage age-related cataracts and may offer a viable non-surgical intervention.
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Originally published in American Journal of Ophthalmology 4 August 2024. This summary does not represent the original research, nor is it intended to replace the original research. Content Disclaimer 


Study Context

Age-related cataracts are a prevalent condition that significantly impact visual function, particularly contrast sensitivity (CS), in older adults. 


Traditional surgical interventions are often the standard treatment in such cases; however, novel therapeutic approaches are emerging, including the use of topical eye drops, that may reduce the need for surgery. The research investigated whether a new ophthalmic solution, specifically a 2.6% EDTA formulation (C-KAD), would provide a non-invasive alternative for managing early cataract symptoms, potentially delaying the need for surgical intervention.
 
In this study, researchers Kuboi  & Chuck et al. analysed a subgroup of a randomized, double-blinded, placebo-controlled, multi-centre Phase 1/2 clinical trial, registered with the FDA (NCT06365762).
 
111 patients (222 eyes) with reduced contrast sensitivity due to low-grade cataracts in both eyes were enrolled.41 eyes from 29 patients were included in the subgroup analysis:
• 21 eyes from 15 patients received the C-KAD treatment
• Twenty eyes from 14 patients received the placebo.
 
Both eyes of subjects in the intent-to-treat population were included if they had baseline mesopic contrast sensitivity (CS) scores between 1 and 7 grating patches (on a scale of 0 to 9, where each patch represents 0.15 logCS) across all five spatial frequencies. 
 
The analysis focused on the proportion of eyes showing clinically significant improvements in mesopic CS, as well as mean changes in CS at spatial frequencies ranging from 1.5 to 18 cycles per degree. Additionally, the study explored best-corrected visual acuity (BCVA) and lens density in a smaller subgroup of eyes for which Scheimpflug imaging data was available.
 
 
The following findings were recorded:

At Day 120, 66.7% of eyes treated with C-KAD showed a ≥ 0.30 logCS improvement in at least two spatial frequencies, compared to 35% in the placebo group. 

Additionally, 42.9% of C-KAD-treated eyes achieved ≥ 0.30 logCS improvement in overall visual function (AULCSF), compared to 15% in the placebo group. 

Positive trends were observed in best-corrected visual acuity (BCVA) and lens density, but further research is needed to clarify the interpretation of lens densitometry results.
 
Based on these findings, the researchers concluded that the 2.6% EDTA ophthalmic solution (C-KAD) significantly improved contrast sensitivity in patients with early-stage age-related cataracts. They also suggested that, given C-KAD's excellent safety profile demonstrated in previous studies, further later-stage confirmatory prospective clinical trials are warranted.
 
It should be noted that a supplementary comment raised concerns about the interpretation of the Scheimpflug imaging data. The commentator questioned whether corneal densitometry was evaluated across all patients and suggested that if the observed trends were consistent for all patients, the conclusions regarding reduced lens densitometry after EDTA treatment might be premature. You can access the comment here


Access the original research article
 

Access supplementary material

The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract. Clinical Trial NCT06365762. Sponsor:Livionex Inc. Last updated: 2024-4-16. Accessed 4 October 2024

Comment on "Subgroup Analysis from a Phase 1/2 Randomized Clinical Trial of 2.6% EDTA Ophthalmic Solution in Patients with Age-Related Cataract" https://www.ajo.com/article/S0002-9394(24)00435-5/abstract


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