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

NCT03321253 | Completed Results DMC FDA Device

• 1 other identifier: 2011-KAEK-2 2017/172
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  2 Months

Study Arms (1)

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

Device: Nd: YAG laser posterior capsulotomy

Interventions

Nd: YAG laser posterior capsulotomy DEVICE

Nd: YAG laser posterior capsulotomy

Also known as: Tango Laserex

Nd: YAG laser posterior capsulotomy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyon Kocatepe University Hospital: lead

MeSH Terms

Conditions

Retinal Degeneration; Retinal Detachment; Choroid Diseases; Macular Edema

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Uveal Diseases; Macular Degeneration

Results Point of Contact

• Title: Dr. Bunyamin Kutluksaman
• Organization: Necip Fazil City Hospital

bkutluksaman@gmail.com

903442282800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: sequential self-controlled clinical trial

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 25, 2017
• Study Start: October 23, 2015
• Primary Completion: April 12, 2016
• Study Completion: May 16, 2016
• Last Updated: August 7, 2019
• Results First Posted: June 28, 2019

Record last verified: 2019-07