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The goal of this observational study is to test whether surgeries for lenses designed to be implanted in the eye to correct refractive error can be done without the need for using viscoelastic substances that are used routinely nowadays to make it easier to introduce them inside the human eye and protect the inside of the eye during the operation.
The main question it aims to answer is that is it safe to do the surgery without using them? to answer this question researchers will access recorded data of patients that underwent refractive surgeries in a private clinic since 2017 and compare them as two groups: those who underwent the traditional procedures and those who had it without the use of dispersive viscoelastics in regard to their vision before and after surgery, their ocular pressure and biomicroscopic analysis of the inside of their corneas before and after surgery.
Records of patients that had undergone ICL implantation surgery in Al-Ferdows private eye hospital in Baghdad between 2017 and 2023 were accessed. Two groups of patients were identified, for the first group the ICL was implanted with the use of both dispersive and cohesive OVDs (traditional OVD group) and for the second one a novel method of implantation was used without utilizing dispersive OVD (reduced OVD) group. Both types of surgery were done by the same surgeon and in the same settings. The operative notes of the OVD group were as follows: under topical anesthesia if the ICL is toric, manual corneal marking is done in the sitting position using pendular marker. After loading of the ICL, two-step clear corneal main incision 2.8 mm in width with a bit long track of 1.5-2 mm to enhance its valve action was fashioned. Intracameral injection of dispersive OVD. The ICL was implanted with mouth-to-mouth technique. Anterior chamber reformation with cohesive OVD, then haptics are gently pushed behind the iris using an olive-tipped manipulator, ensuring alignment to proper axis in case of toric ICL, otherwise spherical ICL is placed directly at 180° axis. After that, AC (anterior chamber) wash with irrigation/aspiration is performed then stromal hydration was done to seal the surgical wound. In the reduced OVD group, modification to the traditional method involved omitting the step of dispersive OVD injection and instead utilizing Intracameral injection of 1:1 mixture of 1:1000 adrenaline and 2% lidocaine in an overfilling manner. All other surgical steps are performed in an identical manner.
The study was ethically approved by the institutional review committee at the respective hospital and a similar committee at the college of medicine of university of Basrah according to the local guidelines and protocols. Written informed consent was obtained from each patient before the surgery. The study followed tenets of declaration of Helsinki.
For both groups, records involving preoperative and postoperative assessments such as uncorrected and best corrected visual acuity, refractive error quantification both objectively utilizing an autorefractometer autorefractor Nidek ARK 1 (Nidek Inc, Gamagori, Japan) and subjectively as manifest refraction, clinical slit-lamp examination notes, intraocular pressure with non-contact air puff tonometer Topcon CT-1P (Topcon Inc., Tokyo, Japan), AC depth assessment by Pentacam Scheimpflug (Oculus Optikgeräte GmbH Inc., Wetzlar, Germany), specular microscopy study of corneal endothelial cells (endothelial cell density (ECD), coefficient of variation (CV) and hexagonality) using Topcon SP-1p Specular Microscope (Topcon Corporation, Tokyo, Japan), were accessed and analyzed using the latest software in SPSS. Patients with missing or incomplete data were excluded from the study. Exclusion criteria also included patients with severe ocular surface disease, unstable refraction, glaucoma, cataract, retinal detachment and uveitis. Unpaired t test or Mann-Whitney test was used to compare the two groups according to fulfilled statistical assumptions. Significance was considered at P value less than 0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional OVD group | In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device. |
| |
| Reduced OVD group | In this group of patients, the ICL was implanted with the use of cohesive OVD only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phakic intraocular lens implantation traditional | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Unaided Visual Acuity After the Procedure | visual acuity (vision of the patient) without use of any glasses measured using LogMar charts. This measure has no specified units | 1-2 years after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure Postoperatively | intraocular 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 | first day, first week and first month after the procedure |
| Specular Microscopy Parameter: Endothelial Cell Density |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications | such as glaucoma, cataract, persistent uveitis, macular edema, endophthalmitis..etc. | any time post op within the maximum 2 years follow up period |
Exclusion Criteria:
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Records of patients that had undergone ICL implantation surgery in Al-Ferdows private eye hospital in Baghdad between 2017 and 2023 were accessed. Two groups of patients were identified, for the first group the ICL was implanted with the use of both dispersive and cohesive OVDs (traditional OVD group) and for the second one, a novel method of implantation was used without utilizing dispersive OVD (reduced OVD) group.
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| Name | Affiliation | Role |
|---|---|---|
| Sohaib A Mahmood, FIBMS | Ibn Al-Haithem eye teaching hospital | Study Chair |
| Loay A Almusawi, FIBMS | University of Basrah | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Ferdows private eye hospital | Baghdad | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32541520 | Background | Peng M, Tang Q, Zhao L, Khan MA, Lin D. Safety of implantable Collamer lens implantation without ophthalmic viscosurgical device: A retrospective cohort study. Medicine (Baltimore). 2020 Jun 12;99(24):e20691. doi: 10.1097/MD.0000000000020691. | |
| 34869472 | Background | Zhang Z, Niu L, Zhao J, Miao H, Chen Z, Shen Y, Chen X, Ye Y, Wang X, Zhou X. Safety of EVO ICL Implantation With an Ophthalmic Viscosurgical Device-Free Technique in the Early 24 h After Surgery. Front Med (Lausanne). 2021 Nov 17;8:764653. doi: 10.3389/fmed.2021.764653. eCollection 2021. |
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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
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2023 |
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| phakic intraocular lens implantation reduced OVD | Device | 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. |
|
|
defined 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) |
| 1-2 years after the surgery |
| Specular Microscopy Parameter: Endothelial Cells Hexagonality | defined 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) | 1-2 years after the surgery |
| Specular Microscopy Parameter: Coefficient of Variation of Corneal Endothelial Cells | The 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). | 1-2 years after the surgery |
| 34659826 | Background | Qin Q, Bao L, He Z, Chen F, Zhu D, Zhang S, Zhang W, Liu Y, Gao R, Xie Z. Pure ICL Implantation: A Novel Ophthalmic Viscosurgical Device-Free Method. J Ophthalmol. 2021 Oct 6;2021:7363267. doi: 10.1155/2021/7363267. eCollection 2021. |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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this involves all participants with complete data
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | eyes |
| ||||||||||||||
| Sex: Female, Male | Count of Units | eyes | eyes |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants | Participants |
| |||||||||||||||
| Anterior Chamber Depth | The central depth of the anterior chamber measured in millimeters from the posterior surface of the cornea to the anterior surface of the crystalline lens | Mean | Standard Deviation | Millimeter | eyes |
| |||||||||||||
| Endothelial Cell Density | Corneal endothelial cell density as measured using specular microscopy preoperatively | Mean | Standard Deviation | cells per square millimeter | Participants |
| |||||||||||||
| Corneal endothelial coefficient of variation | Defined as the ration of the standard deviation of the corneal endothelial cell size to the mean | Mean | Standard Deviation | unitless | eyes |
| |||||||||||||
| Corneal endothelial cells hexagonality | the percentage of corneal endothelial cells with 6 borders from total number of cells in the analyzed area | Mean | Standard Deviation | percentage | eyes |
| |||||||||||||
| Central corneal thickness | Central corneal thickness (CCT) as measured using specular microscopy | Mean | Standard Deviation | micrometer | eyes |
| |||||||||||||
| Intraocular pressure | Mean | Standard Deviation | Millimeters of Mercury | eyes |
| ||||||||||||||
| Unaided visual acuity | Visual acuity measured using Logmar charts before the procedure without any refractive correction | Mean | Standard Deviation | LogMAR | eyes |
| |||||||||||||
| Best-corrected Visual acuity | Mean | Standard Deviation | LogMAR | eyes |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unaided Visual Acuity After the Procedure | visual acuity (vision of the patient) without use of any glasses measured using LogMar charts. This measure has no specified units | Those are participants with complete data and were considered for final statistical analysis | Posted | Mean | Standard Deviation | LogMar vision | 1-2 years after the surgery | Eyes | Eyes |
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| Secondary | Intraocular Pressure Postoperatively | intraocular 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 | Posted | Mean | Standard Deviation | mmHg | first day, first week and first month after the procedure | Eyes | Eyes |
|
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| Secondary | Specular Microscopy Parameter: Endothelial Cell Density | defined 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) | Posted | Mean | Standard Deviation | cells per square millimeter | 1-2 years after the surgery | Eyes | Eyes |
|
| ||||||||||||||||||||||||||||||
| Secondary | Specular Microscopy Parameter: Endothelial Cells Hexagonality | defined 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) | Posted | Mean | Standard Deviation | percentage of hexagonal cells | 1-2 years after the surgery | Eyes | Eyes |
| |||||||||||||||||||||||||||||||
| Secondary | Specular Microscopy Parameter: Coefficient of Variation of Corneal Endothelial Cells | The 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). | Posted | Mean | Standard Deviation | uniteless | 1-2 years after the surgery | Eyes | Eyes |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Postoperative Complications | such as glaucoma, cataract, persistent uveitis, macular edema, endophthalmitis..etc. | Not Posted | any time post op within the maximum 2 years follow up period | Participants |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 46 | 0 | 46 | 1 | 46 |
| EG001 | 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. | 0 | 67 | 0 | 67 | 0 | 67 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma | Eye disorders | Systematic Assessment | glaucoma defined here as a persistent raise in intra-ocular pressure that would require a medication to lower it back to normal or surgery and it does not resolve on its own (not temporary) with or without glaucomatous optic disc damage |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Loay Abdulmutalib Almusawi | Basrah Medical College | 009647705559205 | loay.almusawi@uobasrah.edu.iq |
| Aug 28, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2021 | Jul 17, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D001251 | Astigmatism |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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