Clinical trial NCT03321253: Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
Official title: Changes of Macular Pigment Optical Density and Parameters After Nd: YAG Laser Posterior Capsulotomy in Cases With Posterior Capsule Opacification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Afyon Kocatepe University Hospital
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 38
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: sequential self-controlled clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
timeFrame: 2 months
measure: Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
timeFrame: 2 months
measure: Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
timeFrame: 2 months
measure: Changes of Iridocorneal Angle From Baseline at 2 Months
timeFrame: 2 months
Secondary outcomes:
measure: Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
timeFrame: 2 Months
Other outcomes:
Locations:
Study officials:
References: