Posterior Capsule OpacificationNCT03321253
Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
A study testing Nd: YAG laser posterior capsulotomy in people with Posterior Capsule Opacification and Retinal Degeneration, run by Afyon Kocatepe University Hospital.
Trial summary
It has been hypothesized that potential effects of laser Nd: YAG laser posterior capsulotomy may affect macular pigment as well as choroidal thickness, macular thickness and anterior chamber parameters, so it was aimed to investigate possible effects of Nd: YAG laser posterior capsulotomy on macular pigment optical… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Posterior Capsule Opacification, Retinal Degeneration, Retinal Detachment
- What is being tested?
- Nd: YAG laser posterior capsulotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2015to 16 May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Best-corrected visual acuity (BCVA) logMAR <0.3
- Duration at least 2 years after cataract surgery
- Between the ages of 45 and 65 years (45≤age≤65)
Who cannot join
- Corneal scarring, diffuse posterior PCO or intravitreal hemorrhage that prevents appearance of the fundus
- Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II)
- Presence of macular or peripheral retinal pathologies or choroidopathy
- High risk for RD
- Presence of macular edema in the macular area
- Detection of macular fluid or edema in OCT
Show all 16Show fewer
- Active intraocular inflammation
- Previous laser PRP, Nd: YAG laser posterior capsulotomy, laser iridotomy or selective laser trabeculoplasty interventions
- Previous iridectomy, glaucoma or vitreoretinal surgery
- Glass intraocular lens
- Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
- Inadequate stability of the eye
- 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: Changes of Macular Pigment Optical Density and Parameters After Nd: YAG Laser Posterior Capsulotomy in Cases With Posterior Capsule Opacification
It has been hypothesized that potential effects of laser Nd: YAG laser posterior capsulotomy may affect macular pigment as well as choroidal thickness, macular thickness and anterior chamber parameters, so it was aimed to investigate possible effects of Nd: YAG laser posterior capsulotomy on macular pigment optical density, choroidal thickness, macular thickness and anterior chamber parameters in cases with posterior capsule opacification in this study.
Read the detailed description
This clinical trial was conducted following the principles of the Declaration of Helsinki. The local authorized clinical trials ethics committee approved the protocol and consent forms (Afyon Kocatepe University Clinical Trials Ethics Committee, 2011-KAEK-2 2017/172). Between 2015 and 2016, 38 pseudophakic participants were enrolled in this study. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study.
Detailed ophthalmological examinations of all subjects were performed prior to Nd: YAG laser posterior capsulotomy intervention. Anterior chamber parameters of cases with PCO were measured Measurements of IOP, anterior chamber parameters, visual acuity, Slit-lamp, gonioscopy and fundus examinations, and measurements of central macular thickness (CMT), choroidal thicknesses (CTs), and MPOD were performed after maximal pupil dilatation.
Proposed procedure, including risks, benefits, and alternatives were discussed with all subjects, and all participants signed of informed consent form.
Choroidal thicknesses were recorded as subfoveal CT (SCT), nasal CT (NCT) and temporal CT (TCT).
MPOD measurements were subsequently made by using luminance differential thresholds test. After measurements a refractive surgery specialist carried out Nd: YAG laser posterior capsulotomy interventions to patients who were decided to applying Nd:YAG laser capsulotomy.
All examinations and measurements were repeated and recorded at 1st week, 1st and 2nd month.
- Conditions
- Posterior Capsule Opacification, Retinal Degeneration, Retinal Detachment, Anterior Chamber Angle Congestion, Macula Edema, Macular Pigmentation
- Being tested
- Nd: YAG laser posterior capsulotomy
- Keywords
- Posterior Capsule Opacification, Macular Pigment Optical Density, Anterior Chamber Parameters, Nd: YAG Laser Posterior Capsulotomy, Posterior Capsulotomy, Cystoid Macular Edema, Choroidal Thickness
- Medical subject headings
- Retinal Degeneration, Retinal Detachment, Choroid Diseases, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd: YAG laser posterior capsulotomyDevice
Also called Tango Laserex
Nd: YAG laser posterior capsulotomy
| Study group | Role | What they receive |
|---|---|---|
| Nd: YAG laser posterior capsulotomy | Experimental | Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months Receives: Device: Nd: YAG laser posterior capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months
Measured: 2 months
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Measured: 2 months
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Measured: 2 months
Changes of Iridocorneal Angle From Baseline at 2 Months
Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month
Measured: 2 months
Secondary outcomes (1)
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start23 Oct 2015
- Primary completion12 Apr 2016
- Study completion16 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posterior Capsule OpacificationStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyon Kocatepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bunyamin Kutluksaman, Afyon Kocatepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321253
- Sponsor's protocol ID
- 2011-KAEK-2 2017/172
- Status last verified
- Jul 2019
- First submitted
- 15 Oct 2017
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Macular Pigment Optical Density and Parameters After Nd: YAG Laser Posterior Capsulotomy in Cases With Posterior Capsule Opacification
- ClinicalTrials.gov ID
- NCT03321253
- Acronym / sponsor ID
- 2011-KAEK-2 2017/172
- Conditions
- Posterior Capsule Opacification, Retinal Degeneration, Retinal Detachment, Anterior Chamber Angle Congestion, Macula Edema, Macular Pigmentation
- Keywords
- Posterior Capsule Opacification, Macular Pigment Optical Density, Anterior Chamber Parameters, Nd: YAG Laser Posterior Capsulotomy, Posterior Capsulotomy, Cystoid Macular Edema, Choroidal Thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Afyon Kocatepe University HospitalUniversity, hospital or other
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 12 Apr 2016 (actual)
- Study completion
- 16 May 2016 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 28 Jun 2019
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 potential effects of laser Nd: YAG laser posterior capsulotomy may affect macular pigment as well as choroidal thickness, macular thickness and anterior chamber parameters, so it was aimed to investigate possible effects of Nd: YAG laser posterior capsulotomy on macular pigment optical density, choroidal thickness, macular thickness and anterior chamber parameters in cases with posterior capsule opacification in this study.
Detailed description
This clinical trial was conducted following the principles of the Declaration of Helsinki. The local authorized clinical trials ethics committee approved the protocol and consent forms (Afyon Kocatepe University Clinical Trials Ethics Committee, 2011-KAEK-2 2017/172). Between 2015 and 2016, 38 pseudophakic participants were enrolled in this study. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study.
Detailed ophthalmological examinations of all subjects were performed prior to Nd: YAG laser posterior capsulotomy intervention. Anterior chamber parameters of cases with PCO were measured Measurements of IOP, anterior chamber parameters, visual acuity, Slit-lamp, gonioscopy and fundus examinations, and measurements of central macular thickness (CMT), choroidal thicknesses (CTs), and MPOD were performed after maximal pupil dilatation.
Proposed procedure, including risks, benefits, and alternatives were discussed with all subjects, and all participants signed of informed consent form.
Choroidal thicknesses were recorded as subfoveal CT (SCT), nasal CT (NCT) and temporal CT (TCT).
MPOD measurements were subsequently made by using luminance differential thresholds test. After measurements a refractive surgery specialist carried out Nd: YAG laser posterior capsulotomy interventions to patients who were decided to applying Nd:YAG laser capsulotomy.
All examinations and measurements were repeated and recorded at 1st week, 1st and 2nd month.
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 |
|---|---|---|
| Nd: YAG laser posterior capsulotomy | Experimental | Device: Nd: YAG laser posterior capsulotomyPosterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months |
Who may qualify
- Ages
- 45 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 <0.3
- Duration at least 2 years after cataract surgery
- Between the ages of 45 and 65 years (45≤age≤65)
Key exclusion criteria (16 listed)
- Corneal scarring, diffuse posterior PCO or intravitreal hemorrhage that prevents appearance of the fundus
- Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II)
- Presence of macular or peripheral retinal pathologies or choroidopathy
- High risk for RD
- Presence of macular edema in the macular area
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 |
|---|---|---|
| Nd: YAG laser posterior capsulotomyAlso: Tango LaserexNd: YAG laser posterior capsulotomy | Device | Nd: YAG laser posterior capsulotomy |
Primary outcome
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
Time frame: 2 months
Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
Time frame: 2 months
Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
Time frame: 2 months
Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Changes of Iridocorneal Angle From Baseline at 2 Months
Time frame: 2 months
Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month
1 secondary outcome
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
Time frame: 2 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 Nd: YAG laser posterior capsulotomy in people with Posterior Capsule Opacification 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 16 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 7 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months (time frame: 2 months). The study lists 4 primary outcomes in all. 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 7 Aug 2019.