---
title: Crossover RCT of TAMER Lenses in Myopia Control
nct_id: NCT06329986
overall_status: UNKNOWN
phase: NA
sponsor: Shanghai Eye Disease Prevention and Treatment Center
study_type: INTERVENTIONAL
primary_condition: Myopia
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06329986.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06329986"
ct_last_update_post_date: 2024-03-26
last_seen_at: "2026-05-12T06:18:25.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Crossover RCT of TAMER Lenses in Myopia Control

**Official Title:** A Randomized, Crossover Controlled Trial of the Effect of TAMER Lenses Versus Single Vision Lenses on Myopic Progression in Myopic Children

**NCT ID:** [NCT06329986](https://clinicaltrials.gov/study/NCT06329986)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Shanghai Eye Disease Prevention and Treatment Center
- **Conditions:** Myopia, Progressive
- **Start Date:** 2024-02-24
- **Completion Date:** 2026-01
- **CT.gov Last Update:** 2024-03-26

## Brief Summary

This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses.

## Eligibility

- **Minimum age:** 6 Years
- **Maximum age:** 12 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Race: Chinese children and adolescents.
* Age 6-12 years, gender unrestricted.
* Cycloplegic refraction SER: -0.75DS\~-5.0DS in both eyes.
* Best corrected visual acuity of both eyes reaches 0.8 (0.00 logMAR).
* Cylinder power and astigmatism are no more than 1.5D.
* During the study period, willing to wear glasses provided by the researcher only and without additional interventions.
* Willing to be randomly assigned.
* Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.

Exclusion Criteria:

* Allergic or intolerant to medications used for cycloplegia.
* Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within half a year before the study.
* Diagnosed with any eye disease other than nearsightedness, including strabismus, corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
* History of eye surgery (including strabismus correction surgery).
* Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
* Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
* Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.
```

## Arms

- **Group A** (EXPERIMENTAL) — TAMER lenses are used first for 6 months, followed by SV lenses for 6 months.
- **Group B** (EXPERIMENTAL) — SV lenses are used first for 6 months, followed by TAMER lenses for 6 months.

## Interventions

- **TAMER Lens Spectacle** (DEVICE) — Regular daily wear of TAMER lens spectacle
- **SV lenses** (DEVICE) — SV lenses

## Primary Outcomes

- **Spherical Equivalent change** _(time frame: 6 months)_ — cycloplegic SE change

## Secondary Outcomes

- **Axial Length change** _(time frame: 6 months)_
- **Spherical Equivalent change** _(time frame: 12 months)_

## Locations (1)

- Shanghai Eye Disease Prevention and Treatment Center, Shanghai, Shanghai Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.shanghai eye disease prevention and treatment center|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06329986*  
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