Diabetic RetinopathyNCT03150654
The Effect of Laser Treatment on Macular Pigment of Eye in Cases With Diabetes
A study testing Laser pan-retinal photocoagulation in people with Diabetic Retinopathy and Retinal Degeneration, run by Afyon Kocatepe University Hospital.
Trial summary
It has been hypothesized that thermal damage of laser pan-retinal photocoagulation may affect macular pigment as well as inner layer cells in the retina, so it was aimed to investigate possible effect of conventional laser pan-retinal photocoagulation on macular pigment optical density in diabetic retinopathy patients… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Retinopathy, Retinal Degeneration, Macula Abnormality
- What is being tested?
- Laser pan-retinal photocoagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 12 Jul 2016
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Best corrected visual acuity (BCVA) logMAR ≤0.4
- Newly diagnosis of PDR and initiation of conventional laser PRP treatment
- Between the ages of 40 and 65 years (40≤age≤65)
Who cannot join
- Corneal scarring, cataract or intravitreal hemorrhage that prevents appearance of the fundus
- Presence of macular pathologies such as AMD or choroidopathy
- Presence of macular edema or NVE in the macular area
- Detection of macular fluid or edema in OCT or FFA
- Previous laser PRP treatments
- Focal and / or grid photocoagulation requirements
Show all 12Show fewer
- Previous refractive or vitreoretinal surgery
- Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
- Systemic diseases that may affect the choroidal blood flow such as cardiological diseases
- Current use of carotenoid supplementation
- Changing eating habits
- Gastrointestinal diseases that could cause disturbance of dietary absorption
About this study
Official title: The Effect of Laser Pan-retinal Photocoagulation on Macular Pigment Optical Density in Cases With Diabetic Retinopathy
It has been hypothesized that thermal damage of laser pan-retinal photocoagulation may affect macular pigment as well as inner layer cells in the retina, so it was aimed to investigate possible effect of conventional laser pan-retinal photocoagulation on macular pigment optical density in diabetic retinopathy patients without macular edema and pathology in this study.
Read the detailed description
The local authorized clinical trials ethics committee approved the study and this study was performed following the principles of the Declaration of Helsinki (2008). Detailed information was given to patients about clinical applications and tests, and signed informed consent forms were also obtained from all patients. The 36 eyes of 36 patients, scheduled for laser pan-retinal photocoagulation treatment, with newly diagnosed proliferative diabetic retinopathy without macular edema or scarring between October 2015 - June 2016 were included in this sequential self-controlled clinical trial. Proliferative diabetic retinopathy was diagnosed with determination of neovascular proliferations is either on the disc (NVD) or elsewhere (NVE) except macular area in fundus examination with 90-diopter lens and fundus fluorescein angiography (FFA) (Heidelberg Spectralis, Heidelberg Engineering, Baden-Württemberg, Germany). Patients, detected macular fluid or edema by optical coherence tomography (OCT) (Cirrus HD 4000, Carl Zeis Meditec, CA, USA) in study eye, were excluded in the study. After providing information to patients about the disease and treatment; patients, predicted to show adherence to treatment, were enrolled in the study.
Ophthalmological examinations were performed in all cases. Firstly, visual acuity was recorded, and best-corrected visual acuity (BCVA) assessed using Snellen's chart and was converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis. After maximal pupil dilatation was achieved using 1% tropicamide and 10% phenylephrine eye drops, put once or twice, at ten minute intervals, slit-lamp examination was performed, and fundus was examined with 90-diopter indirect non-contact fundus lens, and ocular finds were recorded.
Prior to measurements the pupil was dilated to at least 7 mm diameter using a topical mydriatic agent. Macular pigment optical density (MPOD) levels were measured in the study eye using luminance differential thresholds test (MonPack System®, Metrovision, Perenchies, France), color perimetry technique at baseline before first PRP laser treatment and every month before laser treatment until the end of this study. The macular pigment absorbs blue light, and luminance differential thresholds test evaluates the density of the macular pigment by comparing the thresholds of perception of blue light and red light with a staircase technique similar to the technique used in automated perimetry. Luminance differential thresholds were measured for 2 stimuli: a blue stimulus (450-480 nm) absorbed by the MP, and a red one (615 nm) not absorbed. The stimuli were presented at the fovea and at 6 peripheral locations with an eccentricity of 3 to 10 degrees (0°, 0.8°, 1.8°, 2.8° and 3.8°, and the average of two measurements at 6.8° and 7.8° retinal eccentricity serves as the peripheral reference point). Tests parameters were Goldmann size III over a white background of 10 cd.m-2. The average values of the tested (decibel=dB) were converted to logarithm units (log unit) for statistical analysis (dB = 10log10 (Reference1/Reference2)). Because, decibel is always the comparison between two values. As a result, the decibel number is the same, although the measured power value is often different. Therefore, arithmetic operations with the numbers expressed in decibels would be inconvenient.
Conventional laser PRP treatments were performed under topical anesthesia by using green laser photocoagulator (GYC-500 Vixi® Nidek, Gamagori, Japan) and Volk® quadraspheric lens. PRP laser were applied in 300mW power, 200-400-500 μm spot size and 0.1-0.2 second pulse options, based upon preferences and comfort levels. When a pattern array was used, the spot separation was set at 0.5 times the burn width.
Laser parameters were evaluated based on a) area (A) (= πr2 × number of shots) r being the spot radius, which is half of the spot size (100-200-250 μm), and it was converted to square millimeters (mm2) for statistical analyses, b) treatment duration (t) (= 0.1 - 0.2 second × number of shots) and c) total energy (E) (= P × t) milijoules (mJ) P being the power, which is 300mW.
All examinations, MPOD and laser PRP parameters were repeated and recorded at 1st, 2nd, 3rd month before laser treatments and 6th month. Changes in the eating habits of patients were questioned at all study visits. All subjects were told to continue their normal diet, as no subjects were consuming supplements containing lutein or zeaxanthin.
- Being tested
- Laser pan-retinal photocoagulation
- Keywords
- macular pigment, macular pigment optical density, diabetic retinopathy, laser pan-retinal photocoagulation
- Medical subject headings
- Diabetic Retinopathy, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser pan-retinal photocoagulationDevice
Also called GYC-500 Vixi
Green laser photocoagulator
| Study group | Role | What they receive |
|---|---|---|
| Laser pan-retinal photocoagulation | Experimental | Conventional laser pan-retinal photocoagulations were performed by using green laser photocoagulator, every month for 3 months Receives: Device: Laser pan-retinal photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change macular pigment optical density from baseline at 6 months
Macular pigment optical density measures were repeated and recorded at 1st, 2nd, 3rd month before laser treatments and 6th month
Measured: 1 month and 3 months
Secondary outcomes (1)
Correlation analysis between macular pigment optical density and panretinal laser photocoagulation parameters during 6 months
The correlations between macular pigment optical density outcomes and panretinal laser photocoagulation parameters (total energy, total area, total shots, total duration) were evaluated for 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Oct 2015
- Primary completion8 Jun 2016
- Study completion12 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies 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
- Intervention model
- Sequential
- Model description
- sequential self-controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyon Kocatepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustafa Dogan, Asst. Prof., Study director, Afyon Kocatepe University Eye Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150654
- Sponsor's protocol ID
- 2011-KAEK-2 2015/323
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Bone RA, Landrum JT, Friedes LM, Gomez CM, Kilburn MD, Menendez E, Vidal I, Wang W. Distribution of lutein and zeaxanthin stereoisomers in the human retina. Exp Eye Res. 1997 Feb;64(2):211-8. doi: 10.1006/exer.1996.0210.
PubMed 9176055Krinsky NI, Landrum JT, Bone RA. Biologic mechanisms of the protective role of lutein and zeaxanthin in the eye. Annu Rev Nutr. 2003;23:171-201. doi: 10.1146/annurev.nutr.23.011702.073307. Epub 2003 Feb 27.
PubMed 12626691Krinsky NI, Johnson EJ. Carotenoid actions and their relation to health and disease. Mol Aspects Med. 2005 Dec;26(6):459-516. doi: 10.1016/j.mam.2005.10.001. Epub 2005 Nov 23.
PubMed 16309738Ma L, Yan SF, Huang YM, Lu XR, Qian F, Pang HL, Xu XR, Zou ZY, Dong PC, Xiao X, Wang X, Sun TT, Dou HL, Lin XM. Effect of lutein and zeaxanthin on macular pigment and visual function in patients with early age-related macular degeneration. Ophthalmology. 2012 Nov;119(11):2290-7. doi: 10.1016/j.ophtha.2012.06.014. Epub 2012 Aug 1.
PubMed 22858124Piermarocchi S, Saviano S, Parisi V, Tedeschi M, Panozzo G, Scarpa G, Boschi G, Lo Giudice G; Carmis Study Group. Carotenoids in Age-related Maculopathy Italian Study (CARMIS): two-year results of a randomized study. Eur J Ophthalmol. 2012 Mar-Apr;22(2):216-25. doi: 10.5301/ejo.5000069.
PubMed 22009916Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013 May 15;309(19):2005-15. doi: 10.1001/jama.2013.4997.
PubMed 23644932Trieschmann M, van Kuijk FJ, Alexander R, Hermans P, Luthert P, Bird AC, Pauleikhoff D. Macular pigment in the human retina: histological evaluation of localization and distribution. Eye (Lond). 2008 Jan;22(1):132-7. doi: 10.1038/sj.eye.6702780. Epub 2007 Mar 30.
PubMed 17401321Powner MB, Gillies MC, Tretiach M, Scott A, Guymer RH, Hageman GS, Fruttiger M. Perifoveal muller cell depletion in a case of macular telangiectasia type 2. Ophthalmology. 2010 Dec;117(12):2407-16. doi: 10.1016/j.ophtha.2010.04.001. Epub 2010 Aug 3.
PubMed 20678804Bone RA, Landrum JT, Fernandez L, Tarsis SL. Analysis of the macular pigment by HPLC: retinal distribution and age study. Invest Ophthalmol Vis Sci. 1988 Jun;29(6):843-9.
PubMed 3372161Morgan CL, Currie CJ, Stott NC, Smithers M, Butler CC, Peters JR. The prevalence of multiple diabetes-related complications. Diabet Med. 2000 Feb;17(2):146-51. doi: 10.1046/j.1464-5491.2000.00222.x.
PubMed 10746486Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
PubMed 15640920Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.
PubMed 2062512Preliminary report on effects of photocoagulation therapy. The Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1976 Apr;81(4):383-96. doi: 10.1016/0002-9394(76)90292-0.
PubMed 944535Stefansson E. Ocular oxygenation and the treatment of diabetic retinopathy. Surv Ophthalmol. 2006 Jul-Aug;51(4):364-80. doi: 10.1016/j.survophthal.2006.04.005.
PubMed 16818083Mainster MA, Reichel E. Transpupillary thermotherapy for age-related macular degeneration: principles and techniques. Semin Ophthalmol. 2001 Jun;16(2):55-9. doi: 10.1076/soph.16.2.55.4213.
PubMed 15491004
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laser Pan-retinal Photocoagulation on Macular Pigment Optical Density in Cases With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03150654
- Acronym / sponsor ID
- 2011-KAEK-2 2015/323
- Keywords
- macular pigment, macular pigment optical density, diabetic retinopathy, laser pan-retinal photocoagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Afyon Kocatepe University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 8 Jun 2016 (actual)
- Study completion
- 12 Jul 2016 (actual)
- First posted
- 12 May 2017 (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.
It has been hypothesized that thermal damage of laser pan-retinal photocoagulation may affect macular pigment as well as inner layer cells in the retina, so it was aimed to investigate possible effect of conventional laser pan-retinal photocoagulation on macular pigment optical density in diabetic retinopathy patients without macular edema and pathology in this study.
Detailed description
The local authorized clinical trials ethics committee approved the study and this study was performed following the principles of the Declaration of Helsinki (2008). Detailed information was given to patients about clinical applications and tests, and signed informed consent forms were also obtained from all patients. The 36 eyes of 36 patients, scheduled for laser pan-retinal photocoagulation treatment, with newly diagnosed proliferative diabetic retinopathy without macular edema or scarring between October 2015 - June 2016 were included in this sequential self-controlled clinical trial. Proliferative diabetic retinopathy was diagnosed with determination of neovascular proliferations is either on the disc (NVD) or elsewhere (NVE) except macular area in fundus examination with 90-diopter lens and fundus fluorescein angiography (FFA) (Heidelberg Spectralis, Heidelberg Engineering, Baden-Württemberg, Germany). Patients, detected macular fluid or edema by optical coherence tomography (OCT) (Cirrus HD 4000, Carl Zeis Meditec, CA, USA) in study eye, were excluded in the study. After providing information to patients about the disease and treatment; patients, predicted to show adherence to treatment, were enrolled in the study.
Ophthalmological examinations were performed in all cases. Firstly, visual acuity was recorded, and best-corrected visual acuity (BCVA) assessed using Snellen's chart and was converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis. After maximal pupil dilatation was achieved using 1% tropicamide and 10% phenylephrine eye drops, put once or twice, at ten minute intervals, slit-lamp examination was performed, and fundus was examined with 90-diopter indirect non-contact fundus lens, and ocular finds were recorded.
Prior to measurements the pupil was dilated to at least 7 mm diameter using a topical mydriatic agent. Macular pigment optical density (MPOD) levels were measured in the study eye using luminance differential thresholds test (MonPack System®, Metrovision, Perenchies, France), color perimetry technique at baseline before first PRP laser treatment and every month before laser treatment until the end of this study. The macular pigment absorbs blue light, and luminance differential thresholds test evaluates the density of the macular pigment by comparing the thresholds of perception of blue light and red light with a staircase technique similar to the technique used in automated perimetry. Luminance differential thresholds were measured for 2 stimuli: a blue stimulus (450-480 nm) absorbed by the MP, and a red one (615 nm) not absorbed. The stimuli were presented at the fovea and at 6 peripheral locations with an eccentricity of 3 to 10 degrees (0°, 0.8°, 1.8°, 2.8° and 3.8°, and the average of two measurements at 6.8° and 7.8° retinal eccentricity serves as the peripheral reference point). Tests parameters were Goldmann size III over a white background of 10 cd.m-2. The average values of the tested (decibel=dB) were converted to logarithm units (log unit) for statistical analysis (dB = 10log10 (Reference1/Reference2)). Because, decibel is always the comparison between two values. As a result, the decibel number is the same, although the measured power value is often different. Therefore, arithmetic operations with the numbers expressed in decibels would be inconvenient.
Conventional laser PRP treatments were performed under topical anesthesia by using green laser photocoagulator (GYC-500 Vixi® Nidek, Gamagori, Japan) and Volk® quadraspheric lens. PRP laser were applied in 300mW power, 200-400-500 μm spot size and 0.1-0.2 second pulse options, based upon preferences and comfort levels. When a pattern array was used, the spot separation was set at 0.5 times the burn width.
Laser parameters were evaluated based on a) area (A) (= πr2 × number of shots) r being the spot radius, which is half of the spot size (100-200-250 μm), and it was converted to square millimeters (mm2) for statistical analyses, b) treatment duration (t) (= 0.1 - 0.2 second × number of shots) and c) total energy (E) (= P × t) milijoules (mJ) P being the power, which is 300mW.
All examinations, MPOD and laser PRP parameters were repeated and recorded at 1st, 2nd, 3rd month before laser treatments and 6th month. Changes in the eating habits of patients were questioned at all study visits. All subjects were told to continue their normal diet, as no subjects were consuming supplements containing lutein or zeaxanthin.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- sequential self-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Laser pan-retinal photocoagulation | Experimental | Device: Laser pan-retinal photocoagulationConventional laser pan-retinal photocoagulations were performed by using green laser photocoagulator, every month for 3 months |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Best corrected visual acuity (BCVA) logMAR ≤0.4
- Newly diagnosis of PDR and initiation of conventional laser PRP treatment
- Between the ages of 40 and 65 years (40≤age≤65)
Key exclusion criteria (12 listed)
- Corneal scarring, cataract or intravitreal hemorrhage that prevents appearance of the fundus
- Presence of macular pathologies such as AMD or choroidopathy
- Presence of macular edema or NVE in the macular area
- Detection of macular fluid or edema in OCT or FFA
- Previous laser PRP treatments
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 |
|---|---|---|
| Laser pan-retinal photocoagulationAlso: GYC-500 VixiGreen laser photocoagulator | Device | Laser pan-retinal photocoagulation |
Primary outcome
Change macular pigment optical density from baseline at 6 months
Time frame: 1 month and 3 months
Macular pigment optical density measures were repeated and recorded at 1st, 2nd, 3rd month before laser treatments and 6th month
1 secondary outcome
Correlation analysis between macular pigment optical density and panretinal laser photocoagulation parameters during 6 months
Time frame: 6 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 12 May 2017.
- Background: PubMed 9176055Bone RA, Landrum JT, Friedes LM, Gomez CM, Kilburn MD, Menendez E, Vidal I, Wang W. Distribution of lutein and zeaxanthin stereoisomers in the human retina. Exp Eye Res. 1997 Feb;64(2):211-8. doi: 10.1006/exer.1996.0210.
- Background: PubMed 12626691Krinsky NI, Landrum JT, Bone RA. Biologic mechanisms of the protective role of lutein and zeaxanthin in the eye. Annu Rev Nutr. 2003;23:171-201. doi: 10.1146/annurev.nutr.23.011702.073307. Epub 2003 Feb 27.
- Background: PubMed 16309738Krinsky NI, Johnson EJ. Carotenoid actions and their relation to health and disease. Mol Aspects Med. 2005 Dec;26(6):459-516. doi: 10.1016/j.mam.2005.10.001. Epub 2005 Nov 23.
- Background: PubMed 22858124Ma L, Yan SF, Huang YM, Lu XR, Qian F, Pang HL, Xu XR, Zou ZY, Dong PC, Xiao X, Wang X, Sun TT, Dou HL, Lin XM. Effect of lutein and zeaxanthin on macular pigment and visual function in patients with early age-related macular degeneration. Ophthalmology. 2012 Nov;119(11):2290-7. doi: 10.1016/j.ophtha.2012.06.014. Epub 2012 Aug 1.
- Background: PubMed 22009916Piermarocchi S, Saviano S, Parisi V, Tedeschi M, Panozzo G, Scarpa G, Boschi G, Lo Giudice G; Carmis Study Group. Carotenoids in Age-related Maculopathy Italian Study (CARMIS): two-year results of a randomized study. Eur J Ophthalmol. 2012 Mar-Apr;22(2):216-25. doi: 10.5301/ejo.5000069.
- Background: PubMed 23644932Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013 May 15;309(19):2005-15. doi: 10.1001/jama.2013.4997.
- Background: PubMed 17401321Trieschmann M, van Kuijk FJ, Alexander R, Hermans P, Luthert P, Bird AC, Pauleikhoff D. Macular pigment in the human retina: histological evaluation of localization and distribution. Eye (Lond). 2008 Jan;22(1):132-7. doi: 10.1038/sj.eye.6702780. Epub 2007 Mar 30.
- Background: PubMed 20678804Powner MB, Gillies MC, Tretiach M, Scott A, Guymer RH, Hageman GS, Fruttiger M. Perifoveal muller cell depletion in a case of macular telangiectasia type 2. Ophthalmology. 2010 Dec;117(12):2407-16. doi: 10.1016/j.ophtha.2010.04.001. Epub 2010 Aug 3.
- Background: PubMed 3372161Bone RA, Landrum JT, Fernandez L, Tarsis SL. Analysis of the macular pigment by HPLC: retinal distribution and age study. Invest Ophthalmol Vis Sci. 1988 Jun;29(6):843-9.
- Background: PubMed 10746486Morgan CL, Currie CJ, Stott NC, Smithers M, Butler CC, Peters JR. The prevalence of multiple diabetes-related complications. Diabet Med. 2000 Feb;17(2):146-51. doi: 10.1046/j.1464-5491.2000.00222.x.
- Background: PubMed 15640920Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
- Background: PubMed 2062512Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.
- Individual participant dataSharing planned: Undecided
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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.
Mustafa Dogan, Asst. Prof. study director
Afyon Kocatepe University Eye Clinics
Questions about this trial
What is this clinical trial studying?
A study testing Laser pan-retinal photocoagulation in people with Diabetic Retinopathy and Retinal Degeneration, run by Afyon Kocatepe University Hospital.
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 3 inclusion and 12 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 12 May 2017. 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. 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?
Change macular pigment optical density from baseline at 6 months (time frame: 1 month and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150654, which also lists 15 linked publications.
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 12 May 2017.