Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03321253|
Recruitment Status : Completed
First Posted : October 25, 2017
Results First Posted : June 28, 2019
Last Update Posted : August 7, 2019
|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|
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 (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||sequential self-controlled clinical trial|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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
- 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
- Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months [ Time Frame: 2 Months ]