## Protocol Section
### Identification Module
**NCT ID:** NCT03381079

**Brief Title:** Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia

**Official Title:** Posterior Scleral Reinforcement for Adults With High Myopia

#### Organization Study ID Info
**ID:** TRECKY2017-049
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tongren Hospital
### Status Module
#### Completion Date
**Date:** 2020-12-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2017-12-22

**Type:** ACTUAL

**Last Update Submit Date:** 2017-12-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-04-01

**Type:** ESTIMATED

**Status Verified Date:** 2017-12

#### Study First Post Date
**Date:** 2017-12-21
**Type:** ACTUAL
**Study First Submit Date:** 2017-12-12
**Study First Submit QC Date:** 2017-12-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Tongren Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing Tongren Hospital

**Investigator Full Name:** Shi-Ming Li

**Investigator Title:** Vice director of Ophthalmology clinical research center

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. Half the adults will receive posterior scleral reinforcement, while the other half will receive no surgerical treatment.

### Conditions Module

**Conditions:**

- High Myopia

- Posterior Scleral Reinforcement

- Adults

- Axial Elongation

- Myopia Progression

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In this arm, the adults with high myopia will be given posterior scleral reinforcement.

**Intervention Names:**

- Procedure: Posterior scleral reinforcement

**Label:** Surgical group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In this arm, the adults with high myopia will not be given any surgical treatment.

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Surgical group

**Description:** Posterior scleral reinforcement (pPSR) is a procedure applied with autologous or biological material or synthetic materials reinforcing pole of the sclera after eyeball, in order to prevent or alleviate myopic development.

**Name:** Posterior scleral reinforcement

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Level of myopia and myopia progression as assessed by autorefraction

**Measure:** Cycloplegic autorefraction

**Time Frame:** 2 years

**Description:** Longth of the eyeball as assessed by IOL Master or Lenstar

**Measure:** Axial length

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc.

**Measure:** Number of participants with treatment-related adverse events

**Time Frame:** 2 years

**Description:** An index for visual function measured by visual acuity chart

**Measure:** Visual acuity

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Cycloplegic spherical equivalent less than -6.0 D
* Myopia progression greater than 1.0 D per year
* Normal IOP, no strabismus or any other ocular pathological changes
* no any other ocular or systematic diseases that may affect refractive development

Exclusion Criteria:

* Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
* Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lishiming81@163.com

**Name:** Shi-Ming Li, PhD

**Phone:** +86-10-58269920

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing Tongren Eye Center, Beijing Tongren Hospital

**Name:** Ningli Wang, PhD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012030

- Term: Refractive Errors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M20559

- Name: Disease Progression

- Relevance: LOW

- As Found: Unknown

- 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

### Misc Info Module

- Version Holder: 2024-05-24
