Trial Outcomes & Findings for Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs (NCT NCT06371079)
NCT ID: NCT06371079
Last Updated: 2024-11-25
Results Overview
visual acuity (vision of the patient) without use of any glasses measured using LogMar charts. This measure has no specified units
Recruitment status
COMPLETED
Target enrollment
448 participants
Primary outcome timeframe
1-2 years after the surgery
Results posted on
2024-11-25
Participant Flow
Data from all patients that had undergone ICL implantation surgery for the correction of refractive errors in Al-Ferdows private eye hospital in Baghdad between 2017 and 2023 were accessed.
The majority of the enrolled subjects were excluded from the study because most of their data were missing in the records. They cannot be analyzed as per study protocol
Unit of analysis: Eyes
Participant milestones
| Measure |
Traditional OVD Group
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
|---|---|---|
|
Overall Study
STARTED
|
134 211
|
314 446
|
|
Overall Study
COMPLETED
|
46 78
|
67 121
|
|
Overall Study
NOT COMPLETED
|
88 133
|
247 325
|
Reasons for withdrawal
| Measure |
Traditional OVD Group
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
|---|---|---|
|
Overall Study
Missing data
|
88
|
247
|
Baseline Characteristics
Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs
Baseline characteristics by cohort
| Measure |
Traditional OVD Group
n=78 eyes
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
n=121 eyes
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
Total
n=199 eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.04 years
STANDARD_DEVIATION 7.39 • n=32 eyes
|
29.07 years
STANDARD_DEVIATION 8.04 • n=16 eyes
|
30.23 years
STANDARD_DEVIATION 7.90 • n=48 eyes
|
|
Sex: Female, Male
Female
|
56 eyes
n=32 eyes
|
79 eyes
n=16 eyes
|
135 eyes
n=48 eyes
|
|
Sex: Female, Male
Male
|
22 eyes
n=32 eyes
|
42 eyes
n=16 eyes
|
64 eyes
n=48 eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Iraq
|
46 participants
n=5 Participants
|
67 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Anterior Chamber Depth
|
3.279 Millimeter
STANDARD_DEVIATION 0.299 • n=32 eyes
|
3.308 Millimeter
STANDARD_DEVIATION 0.241 • n=16 eyes
|
3.297 Millimeter
STANDARD_DEVIATION 0.265 • n=48 eyes
|
|
Endothelial Cell Density
|
2793.75 cells per square millimeter
STANDARD_DEVIATION 310.6 • n=5 Participants
|
2904.56 cells per square millimeter
STANDARD_DEVIATION 307.4 • n=7 Participants
|
2861.47 cells per square millimeter
STANDARD_DEVIATION 312.6 • n=5 Participants
|
|
Corneal endothelial coefficient of variation
|
29.6 unitless
STANDARD_DEVIATION 4.4 • n=32 eyes
|
29.6 unitless
STANDARD_DEVIATION 3.9 • n=16 eyes
|
29.6 unitless
STANDARD_DEVIATION 4.1 • n=48 eyes
|
|
Corneal endothelial cells hexagonality
|
58.22 percentage
STANDARD_DEVIATION 10.55 • n=32 eyes
|
58.30 percentage
STANDARD_DEVIATION 9.77 • n=16 eyes
|
58.27 percentage
STANDARD_DEVIATION 10.07 • n=48 eyes
|
|
Central corneal thickness
|
493.0 micrometer
STANDARD_DEVIATION 38.83 • n=32 eyes
|
491.8 micrometer
STANDARD_DEVIATION 45.60 • n=16 eyes
|
492.3 micrometer
STANDARD_DEVIATION 42.86 • n=48 eyes
|
|
Intraocular pressure
|
15.22 Millimeters of Mercury
STANDARD_DEVIATION 1.9 • n=32 eyes
|
16.79 Millimeters of Mercury
STANDARD_DEVIATION 2.7 • n=16 eyes
|
15.98 Millimeters of Mercury
STANDARD_DEVIATION 2.4 • n=48 eyes
|
|
Unaided visual acuity
|
1.170 LogMAR
STANDARD_DEVIATION 0.196 • n=32 eyes
|
1.177 LogMAR
STANDARD_DEVIATION 0.21 • n=16 eyes
|
1.175 LogMAR
STANDARD_DEVIATION 0.20 • n=48 eyes
|
|
Best-corrected Visual acuity
|
.33 LogMAR
STANDARD_DEVIATION .12 • n=32 eyes
|
.33 LogMAR
STANDARD_DEVIATION .11 • n=16 eyes
|
.33 LogMAR
STANDARD_DEVIATION .11 • n=48 eyes
|
PRIMARY outcome
Timeframe: 1-2 years after the surgeryPopulation: Those are participants with complete data and were considered for final statistical analysis
visual acuity (vision of the patient) without use of any glasses measured using LogMar charts. This measure has no specified units
Outcome measures
| Measure |
Traditional OVD Group
n=78 Eyes
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
n=121 Eyes
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
|---|---|---|
|
Unaided Visual Acuity After the Procedure
|
0.264 LogMar vision
Standard Deviation 0.17
|
0.227 LogMar vision
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: first day, first week and first month after the procedureintraocular pressure in mmHg as measured by non-contact airpuff tonometer Topcon CT-1P (Topcon Inc., Tokyo, Japan). intraocular pressure is measured in millimeters of mercury
Outcome measures
| Measure |
Traditional OVD Group
n=78 Eyes
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
n=121 Eyes
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
|---|---|---|
|
Intraocular Pressure Postoperatively
|
17.44 mmHg
Standard Deviation 4.46
|
17.80 mmHg
Standard Deviation 4.58
|
SECONDARY outcome
Timeframe: 1-2 years after the surgerydefined as the number of corneal endothelial cells per square millimeter of area, measured using the automated machine from Topcon SP-1P (Topcon Inc, Tokyo, Japan)
Outcome measures
| Measure |
Traditional OVD Group
n=78 Eyes
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
n=121 Eyes
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
|---|---|---|
|
Specular Microscopy Parameter: Endothelial Cell Density
|
2785.4 cells per square millimeter
Standard Deviation 417.1
|
2851.0 cells per square millimeter
Standard Deviation 305.1
|
SECONDARY outcome
Timeframe: 1-2 years after the surgerydefined as the percentage of endothelial cells having 6 borders and shaped like a hexagon. this measure reflects the overall health of the endothelial cells and decreased hexagonality below 58-60% indicates corneal enodthelial pleomorphism, also measured using the automated machine from Topcon SP-1P (Topcon Inc, Tokyo, Japan)
Outcome measures
| Measure |
Traditional OVD Group
n=78 Eyes
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
n=121 Eyes
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
|---|---|---|
|
Specular Microscopy Parameter: Endothelial Cells Hexagonality
|
58.69 percentage of hexagonal cells
Standard Deviation 10.43
|
57.93 percentage of hexagonal cells
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: 1-2 years after the surgeryThe standard deviation of the mean cell area divided by the mean cell area gives the coefficient of variation, a unitless number that is normally less than 0.30. it reflects the health of endothelial cells and measured using the automated machine from Topcon SP-1P (Topcon Inc, Tokyo, Japan).
Outcome measures
| Measure |
Traditional OVD Group
n=78 Eyes
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
n=121 Eyes
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
|---|---|---|
|
Specular Microscopy Parameter: Coefficient of Variation of Corneal Endothelial Cells
|
27.37 uniteless
Standard Deviation 3.76
|
29.64 uniteless
Standard Deviation 3.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: any time post op within the maximum 2 years follow up periodsuch as glaucoma, cataract, persistent uveitis, macular edema, endophthalmitis..etc.
Outcome measures
Outcome data not reported
Adverse Events
Traditional OVD Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Reduced OVD Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Traditional OVD Group
n=46 participants at risk
In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.
phakic intraocular lens implantation traditional: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD
|
Reduced OVD Group
n=67 participants at risk
In this group of patients, the ICL was implanted with the use of cohesive OVD only.
phakic intraocular lens implantation reduced OVD: patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.
|
|---|---|---|
|
Eye disorders
Glaucoma
|
2.2%
1/46 • Number of events 1 • within one to two years
All-Cause Mortality, and Serious Adverse Events were monitored/assessed for the same population of participants; However, the majority did not complete the study. PIOL implantation surgery carries a very minimal risk of death or life-threatening events and it is performed under topical local anesthesia. Still certain ocular adverse events may happen and these may include: glaucoma, cataract, retinal detachment, intraocular inflammation and/or infection, macular edema, corneal damage...etc.
|
0.00%
0/67 • within one to two years
All-Cause Mortality, and Serious Adverse Events were monitored/assessed for the same population of participants; However, the majority did not complete the study. PIOL implantation surgery carries a very minimal risk of death or life-threatening events and it is performed under topical local anesthesia. Still certain ocular adverse events may happen and these may include: glaucoma, cataract, retinal detachment, intraocular inflammation and/or infection, macular edema, corneal damage...etc.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place