Clinical trial NCT03932305: Randomized Controlled Trial of LUtein as a Novel Neuroprotective Adjunctive Therapy to Improve Visual Outcome of Rhegmatogenous Retinal Detachment (LUNAR Study)
Official title: Randomized Controlled Trial of LUtein as a Novel Neuroprotective Adjunctive Therapy to Improve Visual Outcome of Rhegmatogenous Retinal Detachment (LUNAR Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2019-04-30
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomisation to placebo or lutein tablets
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Visual acuity
timeFrame: 6 month
Secondary outcomes:
measure: Visual acuity
timeFrame: 12 month
measure: Retinal anatomical changes
timeFrame: 6 and 12 month
measure: Visual function
timeFrame: 6 and 12 month
measure: Quality of life measures
timeFrame: 6 and 12 months
Other outcomes:
Locations:
Study officials:
References: