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)

Sponsors

Lead Sponsor: Singapore National Eye Centre

Source Singapore National Eye Centre
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.

Overall Status Active, not recruiting
Start Date November 24, 2015
Completion Date November 1, 2020
Primary Completion Date October 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual acuity 6 month
Secondary Outcome
Measure Time Frame
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
Enrollment 80
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Lutein

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

Arm Group Label: Lutein

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: Inactive placebo tablet

Arm Group Label: Control

Eligibility

Criteria:

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

- 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

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Singapore Eye Research Institute

Investigator Full Name: Cheung Ning

Investigator Title: Dr

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control

Type: Placebo Comparator

Description: Patients taking inactive placebo tablets

Label: Lutein

Type: Experimental

Description: Patients taking lutein supplement

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 1:1 randomisation to placebo or lutein tablets

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: double-masked for investigators and patients

Source: ClinicalTrials.gov