An interventional study of Nd: YAG laser posterior capsulotomy in Posterior Capsule Opacification, Retinal Degeneration and Retinal Detachment, sponsored by Afyon Kocatepe University Hospital. Completed. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Afyon Kocatepe University Hospital · Not applicable, Interventional, and Treatment
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.
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.
103 studies on the registry are indexed under Retinal Degeneration; 21 are open to participants now.
This study's enrollment of 38 is close to the median of 36 across 74 interventional studies indexed under Retinal Degeneration.
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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
Also known as: Tango Laserex
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 months
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
Time frame: 2 Months
| Milestone | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| Started | 38 |
| Completed | 38 |
| Not completed | 0 |
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
| log unit | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| MPOD fovea at baseline | 0.55 ± 0.07 |
| MPOD fovea at 1-week | 0.52 ± 0.08 |
| MPOD fovea at 1-month | 0.51 ± 0.09 |
| MPOD fovea at 2-month | 0.5 ± 0.09 |
| MPOD pericentral at baseline | 0.33 ± 0.05 |
| MPOD pericentral at 1-week | 0.31 ± 0.05 |
| MPOD pericentral at 1-month | 0.3 ± 0.06 |
| MPOD pericentral at 2-month | 0.29 ± 0.06 |
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
| micrometer | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| Subfoveal choroidal thickness baseline | 276.46 ± 19.36 |
| Subfoveal choroidal thickness at 1-week | 276.54 ± 19.45 |
| Subfoveal choroidal thickness at 1-month | 276.86 ± 19.42 |
| Subfoveal choroidal thickness at 2-month | 276.76 ± 19.36 |
| Temporal choroidal thickness at baseline | 275.04 ± 20.59 |
| Temporal choroidal thickness at 1-week | 275.02 ± 20.67 |
| Temporal choroidal thickness at 1-month | 275.23 ± 20.64 |
| Temporal choroidal thickness at 2-month | 275.03 ± 20.56 |
| Nasal choroidal thickness at baseline | 271.16 ± 19.64 |
| Nasal choroidal thickness at 1-week | 271.33 ± 19.74 |
| Nasal choroidal thickness at 1-month | 271.75 ± 19.71 |
| Nasal choroidal thickness at 2-month | 271.74 ± 19.62 |
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
| millimeter | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| ACD at baseline | 3.7 ± 0.06 |
| ACD at 1-week | 3.73 ± 0.06 |
| ACD at 1-month | 3.74 ± 0.06 |
| ACD at 2-month | 3.75 ± 0.07 |
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
| degree | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| ICA at baseline | 36.59 ± 1.22 |
| ICA at 1-week | 39.92 ± 2.1 |
| ICA at 1-month | 41.62 ± 3.39 |
| ICA at 2-month | 42.04 ± 4.18 |
| micrometer | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| Central Macular Thickness Baseline | 235.79 ± 13.48 |
| Central Macular Thickness 1-week | 243.08 ± 14.32 |
| Central Macular Thickness 1-month | 244.76 ± 14.82 |
| Central Macular Thickness 2-month | 245.5 ± 15.24 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nd: YAG Laser Posterior Capsulotomy | — | — | 0/38 (0%) |
| Age, Categorical(Participants) | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 38 |
| >=65 years | 0 |
| Age, Continuous(years) | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| Mean | 55.37 ± 4.45 |
| Sex: Female, Male(Participants) | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| Female | 19 |
| Male | 19 |
| Region of Enrollment(participants) | Nd: YAG Laser Posterior Capsulotomy |
|---|---|
| Turkey | 38 |
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Plan to share: Undecided
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Afyon Kocatepe University Hospital