Trial Outcomes & Findings for Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification (NCT NCT03321253)

Last Updated: 2019-08-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

2 months

Results posted on

2019-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	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 Nd: YAG laser posterior capsulotomy: Nd: YAG laser posterior capsulotomy
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nd: YAG Laser Posterior Capsulotomy n=38 Participants 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
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	55.37 years STANDARD_DEVIATION 4.45 • n=99 Participants
Sex: Female, Male Female	19 Participants n=99 Participants
Sex: Female, Male Male	19 Participants n=99 Participants
Region of Enrollment Turkey	38 participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Nd: YAG Laser Posterior Capsulotomy n=38 Participants 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
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months MPOD fovea at baseline	0.55 log unit Standard Deviation 0.07
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months MPOD fovea at 1-week	0.52 log unit Standard Deviation 0.08
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months MPOD fovea at 1-month	0.51 log unit Standard Deviation 0.09
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months MPOD fovea at 2-month	0.5 log unit Standard Deviation 0.09
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months MPOD pericentral at baseline	0.33 log unit Standard Deviation 0.05
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months MPOD pericentral at 1-week	0.31 log unit Standard Deviation 0.05
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months MPOD pericentral at 1-month	0.3 log unit Standard Deviation 0.06
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months MPOD pericentral at 2-month	0.29 log unit Standard Deviation 0.06

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Nd: YAG Laser Posterior Capsulotomy n=38 Participants 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
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Subfoveal choroidal thickness baseline	276.46 micrometer Standard Deviation 19.36
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Subfoveal choroidal thickness at 1-week	276.54 micrometer Standard Deviation 19.45
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Subfoveal choroidal thickness at 1-month	276.86 micrometer Standard Deviation 19.42
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Subfoveal choroidal thickness at 2-month	276.76 micrometer Standard Deviation 19.36
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Temporal choroidal thickness at baseline	275.04 micrometer Standard Deviation 20.59
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Temporal choroidal thickness at 1-week	275.02 micrometer Standard Deviation 20.67
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Temporal choroidal thickness at 1-month	275.23 micrometer Standard Deviation 20.64
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Temporal choroidal thickness at 2-month	275.03 micrometer Standard Deviation 20.56
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Nasal choroidal thickness at baseline	271.16 micrometer Standard Deviation 19.64
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Nasal choroidal thickness at 1-week	271.33 micrometer Standard Deviation 19.74
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Nasal choroidal thickness at 1-month	271.75 micrometer Standard Deviation 19.71
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months Nasal choroidal thickness at 2-month	271.74 micrometer Standard Deviation 19.62

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Nd: YAG Laser Posterior Capsulotomy n=38 Participants 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
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months ACD at baseline	3.7 millimeter Standard Deviation 0.06
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months ACD at 1-week	3.73 millimeter Standard Deviation 0.06
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months ACD at 1-month	3.74 millimeter Standard Deviation 0.06
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months ACD at 2-month	3.75 millimeter Standard Deviation 0.07

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Nd: YAG Laser Posterior Capsulotomy n=38 Participants 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
Changes of Iridocorneal Angle From Baseline at 2 Months ICA at 2-month	42.04 degree Standard Deviation 4.18
Changes of Iridocorneal Angle From Baseline at 2 Months ICA at baseline	36.59 degree Standard Deviation 1.22
Changes of Iridocorneal Angle From Baseline at 2 Months ICA at 1-week	39.92 degree Standard Deviation 2.1
Changes of Iridocorneal Angle From Baseline at 2 Months ICA at 1-month	41.62 degree Standard Deviation 3.39

SECONDARY outcome

Timeframe: 2 Months

Outcome measures

Outcome measures
Measure	Nd: YAG Laser Posterior Capsulotomy n=38 Participants 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
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months Central Macular Thickness Baseline	235.79 micrometer Standard Deviation 13.48
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months Central Macular Thickness 1-week	243.08 micrometer Standard Deviation 14.32
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months Central Macular Thickness 1-month	244.76 micrometer Standard Deviation 14.82
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months Central Macular Thickness 2-month	245.5 micrometer Standard Deviation 15.24

Adverse Events

Nd: YAG Laser Posterior Capsulotomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bunyamin Kutluksaman

Necip Fazil City Hospital

Phone: 903442282800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place