Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification

• Sponsor: Afyon Kocatepe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03321253
• Collaborator: (none)
• Enrollment: 38
• Arm: 1
• Actual Duration (Months): 6.8

Study Details

Study Description

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.

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Intervention Model: Sequential Assignment
• Intervention Model Description: sequential self-controlled clinical trialsequential self-controlled clinical trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Oct 23, 2015
• Actual Primary Completion Date: Apr 12, 2016
• Actual Study Completion Date: May 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Tango Laserex

Outcome Measures

Primary Outcome Measures

1. Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months [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

2. Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months [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

3. Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months [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

4. Changes of Iridocorneal Angle From Baseline at 2 Months [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

Secondary Outcome Measures

1. Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months [2 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Afyon Kocatepe University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bunyamin Kutluksaman, Principal Investigator, Afyon Kocatepe University Hospital
• ClinicalTrials.gov Identifier: NCT03321253
• Other Study ID Numbers: 2011-KAEK-2 2017/172
• First Posted: Oct 25, 2017
• Last Update Posted: Aug 7, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Bunyamin Kutluksaman, Principal Investigator, Afyon Kocatepe University Hospital: Posterior Capsule Opacification; Macular Pigment Optical Density; Anterior Chamber Parameters; Nd: YAG Laser Posterior Capsulotomy; Posterior Capsulotomy; Cystoid Macular Edema; Choroidal Thickness
• Additional relevant MeSH terms: Retinal Detachment; Retinal Degeneration; Capsule Opacification; Choroid Diseases

Study Results

Participant Flow

Arm/Group Title	Nd: YAG Laser Posterior Capsulotomy
Arm/Group Description	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
Period Title: Overall Study
STARTED	38
COMPLETED	38
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Nd: YAG Laser Posterior Capsulotomy
Arm/Group Description	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
Overall Participants	38
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	38 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.37 (4.45)
Sex: Female, Male (Count of Participants)
Female	19 50%
Male	19 50%
Region of Enrollment (participants) [Number]
Turkey	38 100%

Outcome Measures

1. Primary Outcome

Title	Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nd: YAG Laser Posterior Capsulotomy
Arm/Group Description	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
Measure Participants	38
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nd: YAG Laser Posterior Capsulotomy
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nd: YAG Laser Posterior Capsulotomy
Arm/Group Description	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
Measure Participants	38
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)

3. Primary Outcome

Title	Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nd: YAG Laser Posterior Capsulotomy
Arm/Group Description	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
Measure Participants	38
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)

4. Primary Outcome

Title	Changes of Iridocorneal Angle From Baseline at 2 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nd: YAG Laser Posterior Capsulotomy
Arm/Group Description	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
Measure Participants	38
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)

5. Secondary Outcome

Title	Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
Time Frame	2 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nd: YAG Laser Posterior Capsulotomy
Arm/Group Description	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
Measure Participants	38
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)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	All-Cause Mortality, and Serious-Adverse Events were not monitored
Arm/Group Title	Nd: YAG Laser Posterior Capsulotomy
Arm/Group Description	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
All Cause Mortality
	Nd: YAG Laser Posterior Capsulotomy
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Nd: YAG Laser Posterior Capsulotomy
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Nd: YAG Laser Posterior Capsulotomy
	Affected / at Risk (%)	# Events
Total	0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.