Clinical Trials Directory

Trials / Completed

CompletedNCT03321253

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Afyon Kocatepe University Hospital · Academic / Other
Sex
All
Age
45 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICENd: YAG laser posterior capsulotomyNd: YAG laser posterior capsulotomy

Timeline

Start date
2015-10-23
Primary completion
2016-04-12
Completion
2016-05-16
First posted
2017-10-25
Last updated
2019-08-07
Results posted
2019-06-28

Regulatory

Source: ClinicalTrials.gov record NCT03321253. Inclusion in this directory is not an endorsement.