Retinal DetachmentNCT03932305
Randomized Controlled Trial of LUtein as a Novel Neuroprotective Adjunctive Therapy to Improve Visual Outcome of Rhegmatogenous Retinal Detachment (LUNAR Study)
A study testing Lutein in people with Retinal Detachment, run by Singapore National Eye Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Lutein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2016to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary macula-off RRD (i.e. one that has not previously been treated with surgery)
- Able and willing to provide informed consent
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Retinal Detachment
- Being tested
- Lutein, Placebo
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuteinDietary supplement
Lutein is a common oral supplement that may have neuroprotective effect on the human retina
PlaceboDietary supplement
Inactive placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients taking inactive placebo tablets Receives: Dietary Supplement: Placebo |
| Lutein | Experimental | Patients taking lutein supplement Receives: Dietary Supplement: Lutein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Changes in best-corrected visual acuity (BCVA) from baseline to 6-month follow-up visit
Measured: 6 month
Secondary outcomes (4)
Visual acuity
Changes in best-corrected visual acuity from baseline to 12-month follow-up visit
Measured: 12 month
Retinal anatomical changes
Recovery of ultrastructural retinal cell layer disruptions on optical coherence tomography scans (e.g., disappearance of outer retinal disruptions at 6 and 12 month visits)
Measured: 6 and 12 month
Visual function
Changes in visual function as measured using Pelli-Robson Contrast Sensitivity and microperimetry testing for macular function
Measured: 6 and 12 month
Quality of life measures
Changes 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.)
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start25 Jul 2016
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomisation to placebo or lutein tablets
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cheung Ning, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932305
- Sponsor's protocol ID
- R1148/50/2014
- Status last verified
- Oct 2022
- First submitted
- 18 Apr 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of LUtein as a Novel Neuroprotective Adjunctive Therapy to Improve Visual Outcome of Rhegmatogenous Retinal Detachment (LUNAR Study)
- ClinicalTrials.gov ID
- NCT03932305
- Acronym / sponsor ID
- R1148/50/2014
- Conditions
- Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomisation to placebo or lutein tablets
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: PlaceboPatients taking inactive placebo tablets |
| Lutein | Experimental | Dietary Supplement: LuteinPatients taking lutein supplement |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary macula-off RRD (i.e. one that has not previously been treated with surgery)
- Able and willing to provide informed consent
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuteinLutein is a common oral supplement that may have neuroprotective effect on the human retina | Dietary supplement | Lutein |
| PlaceboInactive placebo tablet | Dietary supplement | Control |
Primary outcome
Visual acuity
Time frame: 6 month
Changes in best-corrected visual acuity (BCVA) from baseline to 6-month follow-up visit
4 secondary outcomes
Visual acuity
Time frame: 12 month
Retinal anatomical changes
Time frame: 6 and 12 month
Visual function
Time frame: 6 and 12 month
Quality of life measures
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Retinal Detachment
RecruitingPhase 2
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Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lutein in people with Retinal Detachment, run by Singapore National Eye Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.