Refractive ErrorsNCT06371079
Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs
An observational study of Refractive Errors and Myopia, run by Loay Abdulmutalib Almusawi at 1 site in Iraq.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Refractive Errors, Myopia, Myopic Astigmatism
- What is being tested?
- phakic intraocular lens implantation traditional and phakic intraocular lens implantation reduced OVD
- Type of treatment
- Medical device
- How many people
- 448 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2024to 22 Aug 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- patients with refractive errors and stable refraction seeking refractive surgery who are fit for phakic IOL (intraocular lens) implantation and having reasonable improvement of visual acuity with refractive correction.
Who cannot join
- patients with severe ocular surface disease, unstable refraction, glaucoma, cataract, retinal detachment and uveitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Suitability of Implantable Collamer Lens (ICL) Implantation for Correction of Refractive Errors Without the Use of Dispersive Ophthalmic Viscosurgical Devices (OVDs)
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.
Read the detailed description
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.
- Conditions
- Refractive Errors, Myopia, Myopic Astigmatism, Hypermetropia
- Being tested
- phakic intraocular lens implantation traditional, phakic intraocular lens implantation reduced OVD
- Keywords
- refractive errors, myopia, hypermetropia, astigmatism, refractive surgery, ICL, ophthalmic viscosurgical device
- Medical subject headings
- Refractive Errors, Myopia, Astigmatism, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phakic intraocular lens implantation traditionalDevice
Also called ICL implantation traditional, Intraocular refractive surgery
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
phakic intraocular lens implantation reduced OVDDevice
Also called ICL implantation reduced OVD, Intraocular refractive surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional OVD group | In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device. Receives: Device: phakic intraocular lens implantation traditional | |
| Reduced OVD group | In this group of patients, the ICL was implanted with the use of cohesive OVD only. Receives: Device: phakic intraocular lens implantation reduced OVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-2 years after the surgery
Secondary outcomes (4)
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
Measured: first day, first week and first month after the procedure
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)
Measured: 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)
Measured: 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).
Measured: 1-2 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Mar 2024
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 448 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Loay Abdulmutalib Almusawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Loay Abdulmutalib Almusawi, University of Basrah
- Investigators
- Sohaib A Mahmood, FIBMS, Study chair, Ibn Al-Haithem eye teaching hospitalLoay A Almusawi, FIBMS, Study director, University of Basrah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371079
- Sponsor's protocol ID
- NO-OVD-ICL
- Status last verified
- Nov 2024
- First submitted
- 6 Apr 2024
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 32541520Zhang 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.
PubMed 34869472Qin 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.
PubMed 34659826
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Suitability of Implantable Collamer Lens (ICL) Implantation for Correction of Refractive Errors Without the Use of Dispersive Ophthalmic Viscosurgical Devices (OVDs)
- ClinicalTrials.gov ID
- NCT06371079
- Acronym / sponsor ID
- NO-OVD-ICL
- Conditions
- Refractive Errors, Myopia, Myopic Astigmatism, Hypermetropia
- Keywords
- refractive errors, myopia, hypermetropia, astigmatism, refractive surgery, ICL, ophthalmic viscosurgical device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Loay Abdulmutalib AlmusawiUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional OVD group | – | Device: phakic intraocular lens implantation traditionalIn this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device. |
| Reduced OVD group | – | Device: phakic intraocular lens implantation reduced OVDIn this group of patients, the ICL was implanted with the use of cohesive OVD only. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- patients with refractive errors and stable refraction seeking refractive surgery who are fit for phakic IOL (intraocular lens) implantation and having reasonable improvement of visual acuity with refractive correction.
Key exclusion criteria (1 listed)
- patients with severe ocular surface disease, unstable refraction, glaucoma, cataract, retinal detachment and uveitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phakic intraocular lens implantation traditionalAlso: ICL implantation traditional, Intraocular refractive surgerypatients 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 | Device | Traditional OVD group |
| phakic intraocular lens implantation reduced OVDAlso: ICL implantation reduced OVD, Intraocular refractive surgerypatients 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. | Device | Reduced OVD group |
Primary outcome
Unaided Visual Acuity After the Procedure
Time frame: 1-2 years after the surgery
visual acuity (vision of the patient) without use of any glasses measured using LogMar charts. This measure has no specified units
4 secondary outcomes
Intraocular Pressure Postoperatively
Time frame: first day, first week and first month after the procedure
Specular Microscopy Parameter: Endothelial Cell Density
Time frame: 1-2 years after the surgery
Specular Microscopy Parameter: Endothelial Cells Hexagonality
Time frame: 1-2 years after the surgery
Specular Microscopy Parameter: Coefficient of Variation of Corneal Endothelial Cells
Time frame: 1-2 years after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32541520Peng 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.
- Background: PubMed 34869472Zhang 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.
- Background: PubMed 34659826Qin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sohaib A Mahmood, FIBMS study chair
Ibn Al-Haithem eye teaching hospital
Loay A Almusawi, FIBMS study director
University of Basrah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors and Myopia, run by Loay Abdulmutalib Almusawi at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unaided Visual Acuity After the Procedure (time frame: 1-2 years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371079, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.