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Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification

Primary Purpose

Posterior Capsule Opacification, Retinal Degeneration, Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nd: YAG laser posterior capsulotomy
Sponsored by
Afyon Kocatepe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Capsule Opacification focused on measuring Posterior Capsule Opacification, Macular Pigment Optical Density, Anterior Chamber Parameters, Nd: YAG Laser Posterior Capsulotomy, Posterior Capsulotomy, Cystoid Macular Edema, Choroidal Thickness

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Nd: YAG laser posterior capsulotomy

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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

    Secondary Outcome Measures

    Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months

    Full Information

    First Posted
    October 15, 2017
    Last Updated
    July 28, 2019
    Sponsor
    Afyon Kocatepe University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03321253
    Brief Title
    Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
    Official Title
    Changes of Macular Pigment Optical Density and Parameters After Nd: YAG Laser Posterior Capsulotomy in Cases With Posterior Capsule Opacification
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 23, 2015 (Actual)
    Primary Completion Date
    April 12, 2016 (Actual)
    Study Completion Date
    May 16, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Afyon Kocatepe University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posterior Capsule Opacification, Retinal Degeneration, Retinal Detachment, Anterior Chamber Angle Congestion, Macula Edema, Macular Pigmentation, Choroid Disease
    Keywords
    Posterior Capsule Opacification, Macular Pigment Optical Density, Anterior Chamber Parameters, Nd: YAG Laser Posterior Capsulotomy, Posterior Capsulotomy, Cystoid Macular Edema, Choroidal Thickness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    sequential self-controlled clinical trial
    Masking
    None (Open Label)
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nd: YAG laser posterior capsulotomy
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Nd: YAG laser posterior capsulotomy
    Other Intervention Name(s)
    Tango Laserex
    Intervention Description
    Nd: YAG laser posterior capsulotomy
    Primary Outcome Measure Information:
    Title
    Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
    Description
    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
    Time Frame
    2 months
    Title
    Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
    Description
    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
    Time Frame
    2 months
    Title
    Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
    Description
    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
    Time Frame
    2 months
    Title
    Changes of Iridocorneal Angle From Baseline at 2 Months
    Description
    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
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
    Time Frame
    2 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification

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