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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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ClinicalTrials.gov Identifier: NCT03321253
Recruitment Status : Completed
First Posted : October 25, 2017
Results First Posted : June 28, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Bunyamin Kutluksaman, Afyon Kocatepe University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Posterior Capsule Opacification Retinal Degeneration Retinal Detachment Anterior Chamber Angle Congestion Macula Edema Macular Pigmentation Choroid Disease Device: Nd: YAG laser posterior capsulotomy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Sequential Assignment
Intervention Model Description: sequential self-controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes of Macular Pigment Optical Density and Parameters After Nd: YAG Laser Posterior Capsulotomy in Cases With Posterior Capsule Opacification
Actual Study Start Date : October 23, 2015
Actual Primary Completion Date : April 12, 2016
Actual Study Completion Date : May 16, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nd: YAG laser posterior capsulotomy
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
 Device: Nd: YAG laser posterior capsulotomy
Nd: YAG laser posterior capsulotomy
Other Name: Tango Laserex


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months [ Time Frame: 2 Months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Bunyamin Kutluksaman, Principal Investigator, Afyon Kocatepe University Hospital
ClinicalTrials.gov Identifier: NCT03321253    
Other Study ID Numbers: 2011-KAEK-2 2017/172
First Posted: October 25, 2017    Key Record Dates
Results First Posted: June 28, 2019
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Bunyamin Kutluksaman, Afyon Kocatepe University Hospital:
Posterior Capsule Opacification
Macular Pigment Optical Density
Anterior Chamber Parameters
Nd: YAG Laser Posterior Capsulotomy
 Posterior Capsulotomy
Cystoid Macular Edema
Choroidal Thickness
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Degeneration
Capsule Opacification
Choroid Diseases
Retinal Diseases
 Eye Diseases
Eye Diseases, Hereditary
Cataract
Lens Diseases
Uveal Diseases