## Protocol Section
### Identification Module
**NCT ID:** NCT06371079

**Brief Title:** Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs

**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)

#### Organization Study ID Info
**ID:** NO-OVD-ICL
#### Organization
**Class:** OTHER
**Full Name:** University of Basrah
### Status Module
#### Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-04-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-06
**Study First Submit QC Date:** 2024-04-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Loay Abdulmutalib Almusawi

#### Responsible Party

**Investigator Affiliation:** University of Basrah

**Investigator Full Name:** Loay Abdulmutalib Almusawi

**Investigator Title:** Ophthalmology Lecturer

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

### Description Module

**Brief 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 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.

### Conditions Module

**Conditions:**

- Refractive Errors

- Myopia

- Myopic Astigmatism

- Hypermetropia

**Keywords:**

- refractive errors

- myopia

- hypermetropia

- astigmatism

- refractive surgery

- ICL

- ophthalmic viscosurgical device

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Year

### Arms Interventions Module

#### Arm Group 1

**Description:** In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.

**Intervention Names:**

- Device: phakic intraocular lens implantation traditional

**Label:** Traditional OVD group

#### Arm Group 2

**Description:** In this group of patients, the ICL was implanted with the use of cohesive OVD only.

**Intervention Names:**

- Device: phakic intraocular lens implantation reduced OVD

**Label:** Reduced OVD group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Traditional OVD group

**Description:** 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

**Name:** phakic intraocular lens implantation traditional

**Other Names:**

- ICL implantation traditional

- Intraocular refractive surgery

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Reduced OVD group

**Description:** 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.

**Name:** phakic intraocular lens implantation reduced OVD

**Other Names:**

- ICL implantation reduced OVD

- Intraocular refractive surgery

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** such as glaucoma, cataract, persistent uveitis, macular edema, endophthalmitis..etc.

**Measure:** postoperative complications

**Time Frame:** any time post op within the maximum 2 years follow up period

#### Primary Outcomes

**Description:** visual acuity (vision of the patient) without use of any glasses measured using LogMar charts. This measure has no specified units

**Measure:** unaided visual acuity after the procedure

**Time Frame:** 1-2 years after the surgery

**Description:** visual acuity with use of full correction with glasses measured using LogMar charts. This measure has no specified units

**Measure:** best corrected visual acuity after the procedure

**Time Frame:** 1-2 years after the surgery

#### Secondary Outcomes

**Description:** 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

**Measure:** Intraocular pressure postoperatively

**Time Frame:** first day, first week and first month after the procedure

**Description:** 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)

**Measure:** Specular microscopy parameter: endothelial cell density

**Time Frame:** 1-2 years after the surgery

**Description:** 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)

**Measure:** Specular microscopy parameter: endothelial cells hexagonality

**Time Frame:** 1-2 years after the surgery

**Description:** 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).

**Measure:** Specular microscopy parameter: coefficient of variation of corneal endothelial cells

**Time Frame:** 1-2 years after the surgery

### Eligibility Module

**Eligibility Criteria:** * Inclusion Criteria:
* 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.

Exclusion Criteria:

* patients with severe ocular surface disease, unstable refraction, glaucoma, cataract, retinal detachment and uveitis.

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** loay.almusawi@uobasrah.edu.iq

**Name:** Loay Almusawi, FIBMS

**Phone:** 009647705559205

**Role:** CONTACT

**Contact 2:**

**Email:** sohaib.mahmood@meciq.edu.iq

**Name:** Sohaib A Mahmood, CABMS

**Phone:** 00971585358111

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Baghdad

**Contacts:**

***Contact 1:***

- **Email:** sohaib.mahmood@meciq.edu.iq

- **Name:** Sohaib A Mahmood, CABMS

- **Phone:** 00971585358111

- **Role:** CONTACT

***Contact 2:***

- **Email:** Ferdouseyeshospital@yahoo.com

- **Name:** Sami A Hasoon

- **Phone:** +9647901867279

- **Role:** CONTACT

***Contact 3:***

- **Name:** Sohaib A Mahmood, CABMS

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Loay A Almusawi, FIBMS

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Hamid M Altaha, CABMS

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Bashar Alwash, CABMS

- **Role:** SUB_INVESTIGATOR

**Country:** Iraq

**Facility:** Al-Ferdows private eye hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Ibn Al-Haithem eye teaching hospital

**Name:** Sohaib A Mahmood, FIBMS

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** University of Basrah

**Name:** Loay A Almusawi, FIBMS

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 32541520

**Citation:** 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.

**PMID:** 34869472

**Citation:** 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.

**PMID:** 34659826

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12168

- Name: Myopia

- Relevance: HIGH

- As Found: Myopia

- ID: M4558

- Name: Astigmatism

- Relevance: HIGH

- As Found: Astigmatism

- ID: M10007

- Name: Hyperopia

- Relevance: HIGH

- As Found: Hypermetropia

- ID: M14872

- Name: Refractive Errors

- Relevance: HIGH

- As Found: Refractive Errors

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009216

- Term: Myopia

- ID: D000001251

- Term: Astigmatism

- ID: D000012030

- Term: Refractive Errors

- ID: D000006956

- Term: Hyperopia

### Misc Info Module

- Version Holder: 2024-05-24
