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

NCT03932305 | Completed DMC

• 1 other identifier: R1148/50/2014
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Changes in best-corrected visual acuity (BCVA) from baseline to 6-month follow-up visit

  6 month

Secondary Outcomes (4)

• Visual acuity

  12 month

• Retinal anatomical changes

  6 and 12 month

• Visual function

  6 and 12 month

• Quality of life measures

  6 and 12 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients taking inactive placebo tablets

Dietary Supplement: Placebo

Lutein

EXPERIMENTAL

Patients taking lutein supplement

Dietary Supplement: Lutein

Interventions

Lutein DIETARY_SUPPLEMENT

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

Lutein

Placebo DIETARY_SUPPLEMENT

Inactive placebo tablet

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore National Eye Centre: lead

MeSH Terms

Conditions

Retinal Detachment

Interventions

Lutein

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-masked for investigators and patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 1:1 randomisation to placebo or lutein tablets

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 30, 2019
• Study Start: July 25, 2016
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: November 2, 2022

Record last verified: 2022-10