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Randomized Controlled Trial of LUtein as a Novel Neuroprotective Adjunctive Therapy to Improve Visual Outcome of Rhegmatogenous Retinal Detachment (LUNAR Study)

Randomized Controlled Trial of LUtein as a Novel Neuroprotective Adjunctive Therapy to Improve Visual Outcome of Rhegmatogenous Retinal Detachment (LUNAR Study)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03932305
Enrollment
110
Registered
2019-04-30
Start date
2016-07-25
Completion date
2020-11-30
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Brief summary

Retinal detachment is a major cause of blindness, particularly among contemporary Asian populations due to the high prevalence of myopia. Without timely treatment, retinal detachment invariably results in blindness. As the only effective treatment is surgery, much effort has been invested to enhancing surgical outcome of retinal detachment repair. Advances in new instrumentations, viewing systems and refined surgical techniques have all contributed to improved rate of retinal re-attachment (anatomical outcome). Nevertheless, successful re-attachment of the retina after surgery does not always restore vision (visual outcome), especially when retinal detachment involves the macula (macula-off retinal detachment). The reason for poor visual outcome is believed to be due to apoptosis of photoreceptors, which may occur early and rapidly after the onset of retinal detachment. Neuroprotection has therefore been considered a valid strategy to improve visual outcome of retinal detachment surgery. Lutein is a promising potent neuroprotective agent for the retina, and has been shown in preliminary clinical and laboratory studies that it could salvage photorecepters in retinal detachment. We hypothesize that oral intake of lutein soon after onset of retinal detachment could prevent photoreceptor neurons from dying and thus limit the loss of vision. To test such hypothesis, we propose to conduct a double-masked, randomized controlled trial to evaluate the efficacy of lutein as an adjuvant therapy to improve visual outcome for surgical repair of primary rhematogenous retinal detachment involving the macula in Asian Singaporeans. The potential clinical and scientific significance of this trial is clear. It may provide first evidence that pharmacological neuroprotection can be used as an effective therapeutic modality in the clinical management of retinal detachment, and result in a paradigm shift in clinical practice, ultimately leading to better visual outcome and quality of life for patients undertaking surgical repair of retinal detachment.

Detailed description

Retinal detachment is a major cause of blindness, particularly among contemporary Asian populations due to the high prevalence of myopia. Without timely treatment, retinal detachment invariably results in blindness. As the only effective treatment is surgery, much effort has been invested to enhancing surgical outcome of retinal detachment repair. Advances in new instrumentations, viewing systems and refined surgical techniques have all contributed to improved rate of retinal re-attachment (anatomical outcome). Nevertheless, successful re-attachment of the retina after surgery does not always restore vision (visual outcome), especially when retinal detachment involves the macula (macula-off retinal detachment). The reason for poor visual outcome is believed to be due to apoptosis of photoreceptors, which may occur early and rapidly after the onset of retinal detachment. Neuroprotection has therefore been considered a valid strategy to improve visual outcome of retinal detachment surgery. Lutein is a promising potent neuroprotective agent for the retina, and has been shown in preliminary clinical and laboratory studies that it could salvage photorecepters in retinal detachment. We hypothesize that oral intake of lutein soon after onset of retinal detachment could prevent photoreceptor neurons from dying and thus limit the loss of vision. To test such hypothesis, we propose to conduct a double-masked, randomized controlled trial to evaluate the efficacy of lutein as an adjuvant therapy to improve visual outcome for surgical repair of primary rhematogenous retinal detachment involving the macula in Asian Singaporeans. The potential clinical and scientific significance of this trial is clear. It may provide first evidence that pharmacological neuroprotection can be used as an effective therapeutic modality in the clinical management of retinal detachment, and result in a paradigm shift in clinical practice, ultimately leading to better visual outcome and quality of life for patients undertaking surgical repair of retinal detachment.

Interventions

DIETARY_SUPPLEMENTLutein

Lutein is a common oral supplement that may have neuroprotective effect on the human retina

DIETARY_SUPPLEMENTPlacebo

Inactive placebo tablet

Sponsors

Singapore National Eye Centre
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double-masked for investigators and patients

Intervention model description

1:1 randomisation to placebo or lutein tablets

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary macula-off RRD (i.e. one that has not previously been treated with surgery) * Able and willing to provide informed consent

Exclusion criteria

* Known pre-existing macular other ocular diseases (e.g., age-related macular degeneration, myopic maculopathy, diabetic macular edema, corneal diseases) * Trauma-related RRD * Recurrent RRD * Macula-on RRD * Chronic RRD (symptoms \>60 days) * History of amblyopia in the affected eye * Known allergy to or current use of lutein supplements * Pregnant or breastfeeding women, children (age \<21 years), prisoners, cognitively impaired persons

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity6 monthChanges in best-corrected visual acuity (BCVA) from baseline to 6-month follow-up visit

Secondary

MeasureTime frameDescription
Visual acuity12 monthChanges in best-corrected visual acuity from baseline to 12-month follow-up visit
Retinal anatomical changes6 and 12 monthRecovery of ultrastructural retinal cell layer disruptions on optical coherence tomography scans (e.g., disappearance of outer retinal disruptions at 6 and 12 month visits)
Visual function6 and 12 monthChanges in visual function as measured using Pelli-Robson Contrast Sensitivity and microperimetry testing for macular function
Quality of life measures6 and 12 monthsChanges in Impact of Vision Impairment Profile based on vision impairment validated questionnaires (Lamoureux EL, Pallant JF, Pesudovs K, Rees G, Hassell JB, Keeffe JE. The impact of vision impairment questionnaire: an assessment of its domain structure using confirmatory factor analysis and rasch analysis. Invest Ophthalmol Vis Sci. 2007;48(3):1001-1006.)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026