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

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.

Study Overview

• Status: Completed
• Conditions: Retinal Degeneration; Macula Edema; Retinal Detachment; Posterior Capsule Opacification; Macular Pigmentation; Choroid Disease; Anterior Chamber Angle Congestion
• Intervention / Treatment: Device: Nd: YAG laser posterior capsulotomy

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Tango Laserex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months	2 Months

Collaborators and Investigators

• Sponsor: Afyon Kocatepe University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2015
• Primary Completion (ACTUAL): April 12, 2016
• Study Completion (ACTUAL): May 16, 2016

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: October 21, 2017
• First Posted (ACTUAL): October 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2019
• Last Update Submitted That Met QC Criteria: July 28, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Cystoid Macular Edema; Macular Pigment Optical Density; Posterior Capsule Opacification; Anterior Chamber Parameters; Nd: YAG Laser Posterior Capsulotomy; Posterior Capsulotomy; Choroidal Thickness
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Uveal Diseases; Eye Diseases, Hereditary; Lens Diseases; Cataract; Retinal Detachment; Retinal Degeneration; Capsule Opacification; Choroid Diseases
• Other Study ID Numbers: 2011-KAEK-2 2017/172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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