NCT06704503

Brief Summary

Accommodation is defined as a dynamic change in the overall refractive power of the eye during near fixation. Despite extensive investigations, the exact nature of human accommodation remains controversial. And recent alternative theories question the original concept of accommodation.Different experts have put forward different hypotheses. The age-related changes that underlie presbyopia are also not fully understood.Because of these unanswered questions, the topic of regulation and presbyopia remains a focus of research.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Nov 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Nov 2024Dec 2028

First Submitted

Initial submission to the registry

November 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

November 27, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

4.1 years

First QC Date

November 17, 2024

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (13)

  • Central corneal thickness changes during accommodation

    Central corneal thickness CCT(μm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • peripheral corneal thickness changes during accommodation

    peripheral corneal thickness(μm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • anterior chamber depth changes during accommodation

    anterior chamber depth ACD(mm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • anterior chamber Angle Angle changes during accommodation

    anterior chamber Angle Angle ACA(°)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • anterior opening distance changes during accommodation

    anterior opening distance AOD(mm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • pupil size changes during accommodation

    pupil size PD(mm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • lens thickness changes during accommodation

    lens thickness LT(mm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • anterior and posterior surface curvature radius changes during accommodation

    anterior and posterior surface curvature radius(mm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • lens arch height changes during accommodation

    lens arch height LV(mm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • lens sagittal height changes during accommodation

    lens sagittal height(mm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • anterior chamber volume changes during accommodation

    anterior chamber volume(mm³)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • posterior chamber volume changes during accommodation

    posterior chamber volume(mm³)

    Baseline, after accommodation(30 minutes after using pilocarpine)

  • crystal equatorial diameter changes during accommodation

    crystal equatorial diameter(mm)

    Baseline, after accommodation(30 minutes after using pilocarpine)

Study Arms (3)

Group A was 20-40 years old

They were divided into three groups according to age: A, B, and C.Group A was 20-40 years old.

Group B was 40-60 years old

They were divided into three groups according to age: A, B, and C. Group B was 40-60 years old.

Group C was 60-80 years old

They were divided into three groups according to age: A, B, and C. Group C was 60-80 years old.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Age 20-80 years old; Astigmatism ≤-1.50D; Best corrected visual acuity ≥4.9;Excluding other systemic underlying diseases; Have a history of eye surgery; Patients with intraocular lens or aphakia; Patients with strabismus and amblyopia; Pregnant or lactating women; People with mental disorders or neurological diseases who cannot cooperate with the examination;

You may qualify if:

  • · Patients with astigmatism ≤-1.50D and best corrected visual acuity ≥4.9

You may not qualify if:

  • Patients with other systemic diseases
  • Patients with a history of eye surgery
  • Patients with intraocular lens or aphakia
  • Patients with strabismus and amblyopia
  • Pregnant or lactating women
  • People with mental disorders or neurological diseases who cannot cooperate with the examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Age 20-80 years old; Astigmatism ≤-1.50D; Best corrected visual acuity ≥4.9. Excluding people with other systemic underlying diseases; Have a history of eye surgery; Patients with intraocular lens or aphakia; Patients with strabismus and amblyopia; Pregnant or lactating women; People with mental disorders or neurological diseases who cannot cooperate with the examination;

Study Officials

  • Wen Xu, Phd

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2024

First Posted

November 26, 2024

Study Start

November 27, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations