N/A
N=38
Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
Posterior Capsule Opacification · Retinal Degeneration · Retinal Detachment · Anterior Chamber Angle Congestion · Macula Edema
Bottom Line
View on ClinicalTrials.gov: NCT03321253 ↗Enrolled (actual)
38
Serious AEs
—
Results posted
Jun 2019
Primary outcome: Primary: Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months — 0.55; 0.52; 0.51; 0.5 log unit — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nd: YAG laser posterior capsulotomy (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Afyon Kocatepe University Hospital
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months |
0.55; 0.52; 0.51; 0.5; 0.33; 0.31 | <0.01 sig |
| PRIMARY Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months |
276.46; 276.54; 276.86; 276.76; 275.04; 275.02 | — |
| PRIMARY Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months |
3.7; 3.73; 3.74; 3.75 | — |
| PRIMARY Changes of Iridocorneal Angle From Baseline at 2 Months |
36.59; 39.92; 41.62; 42.04 | — |
| SECONDARY Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months |
235.79; 243.08; 244.76; 245.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03321253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.