## Protocol Section
### Identification Module
**NCT ID:** NCT06431841

**Acronym:** DIMS

**Brief Title:** Efficacy and Safety of Atropine and DIMS Lenses in Controlling Myopia in Children: A Randomized Clinical Trial.

**Official Title:** Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population.

#### Organization Study ID Info
**ID:** 21/522-EC_M
#### Organization
**Class:** OTHER
**Full Name:** Hospital San Carlos, Madrid
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-02-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-13
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital San Carlos, Madrid

#### Responsible Party

**Investigator Affiliation:** Hospital San Carlos, Madrid

**Investigator Full Name:** Noemi Guemes

**Investigator Title:** Principal Investigator and sponsor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial involving 50 subjects in each treatment arm (100 patients in total). The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.

### Conditions Module

**Conditions:**

- Myopia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Atropine 0,025% + DIMS Lenses

**Intervention Names:**

- Drug: Atropine 0,025% + DIMS/monofocal Lenses

**Label:** DIMS Lenses

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Atropine 0,025% + monofocal (single vision) Lenses

**Intervention Names:**

- Drug: Atropine 0,025% + DIMS/monofocal Lenses

**Label:** Monofocal Lenses

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- DIMS Lenses

- Monofocal Lenses

**Description:** Atropine 0,025% (1 drop per day) + DIMS/monofocal Lenses

**Name:** Atropine 0,025% + DIMS/monofocal Lenses

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Cycloplegic spherical equivalent refraction (SER) change

**Measure:** Cycloplegic spherical equivalent refraction (SER) change

**Time Frame:** 2 years (24 months)

**Description:** Axial length (AL) change

**Measure:** Axial length (AL) change

**Time Frame:** 2 years (24 months)

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria

* Age between 4-16 years.
* Signing of informed consent.
* Refractive error: myopia greater than -1.00 diopters (D).
* Myopia progression of at least -0.50 D in the last 12 months.
* Astigmatism of 2 D or less and anisometropia of 1.50 D or less.
* Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better.

Exclusion criteria

* Children under 4 years old and over 16 years old
* Strabismus and binocular vision anomalies.
* Alterations in eye fundus that the researcher consider necessary the patient exclution.
* Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision
* Amblyopia
* Previous eye surgery
* Systemic pathology (cardiopulmonary pathology, connective tissue alterations, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation)
* Previous myopia control treatments including orthokeratology, rigid contact lenses, bifocal or myopia control soft contact lenses, bifocal and multifocal ophthalmic lenses within 3 months prior to the study.

**Maximum Age:** 16 Years

**Minimum Age:** 4 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** noemiguemes@gmail.com

**Name:** Noemi Guemes, PHD

**Phone:** 913303000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Name:** Noemi Guemes

- **Phone:** +34913303000

- **Role:** CONTACT

***Contact 2:***

- **Email:** fibucicec.hcsc@salud.madrid.org

- **Name:** uicec

- **Phone:** +34913303000

- **Role:** CONTACT

***Contact 3:***

- **Name:** Noemi Guemes

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Noemi Guemes

**Status:** RECRUITING

**Zip:** 28040

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012030

- Term: Refractive Errors

- 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: M14872

- Name: Refractive Errors

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009216

- Term: Myopia

### Intervention Browse Module - Ancestors

- ID: D000000759

- Term: Adjuvants, Anesthesia

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000001993

- Term: Bronchodilator Agents

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000009184

- Term: Mydriatics

- ID: D000010276

- Term: Parasympatholytics

- ID: D000018727

- Term: Muscarinic Antagonists

- ID: D000018680

- Term: Cholinergic Antagonists

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

### Intervention Browse Module - Browse Leaves

- ID: M4590

- Name: Atropine

- Relevance: HIGH

- As Found: Young Adults

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12139

- Name: Mydriatics

- Relevance: LOW

- As Found: Unknown

- ID: M13189

- Name: Parasympatholytics

- Relevance: LOW

- As Found: Unknown

- ID: M20801

- Name: Muscarinic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20760

- Name: Cholinergic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001285

- Term: Atropine

### Misc Info Module

- Version Holder: 2024-05-31
