The Effect of 0.01% Atropine Eye Drops on Axial Length an... | NCT07456488

Studies
The Effect of 0.01% Atropine Eye Drops on Axial Length and Refraction in Myopic Children Compared to a Control Group

NCT07456488

Sponsor

Liaquat National Hospital & Medical College

Status

Recruiting

Last Update Posted

Mar 6, 2026Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Focus on Axial Length

Interventions

Atropine 0.01% eye drops

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2025Actual

Primary Completion Date

Apr 17, 2026Estimated

Completion Date

Apr 30, 2026Estimated

First Submitted Date

Feb 26, 2026

First Submission Date that Met QC Criteria

Mar 3, 2026

First Posted Date

Mar 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hina Nadeem, Dr. Hina Nadeem, principal Investigator, Liaquat National Hospital & Medical CollegePrincipal Investigator

Lead Sponsor

Liaquat National Hospital & Medical CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, atropine 0.01% eye drops will be given to myopic children once at night daily for 6 months as compared to a control group to see the effect on axial length and refraction

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Atropine 0.01% eye drops	Drug: Atropine 0.01% eye drops
Group B	No Intervention	No eye drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atropine 0.01% eye drops	Drug	Eye drops atropine 0.01% given once nightly to group A for 6 months	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in axial length in mm	Axial length is measured at the time of recruiting the participants and after the end of study	6 months
Change in refraction in Diopters	Refraction is measured at the start of study then after 6 months of study	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 4-16 years
Both genders
Myopia of baseline SER of -1.00D or more
Astigmatism less than or equal to -2.50D
No medical history predisposing severe myopia (e.g., Marfan syndrome, Stickler syndrome, and retinopathy of prematurity), abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, and spherophakia)
No history of other vision-threatening ocular diseases or previous intraocular surgery.
No current or previous use of atropine or pirenzipine, contact lenses or other forms of treatment that may affect myopia progression.

Exclusion Criteria:

Astigmatism ≥ 2.5 D
Anisometropia>1 D
Best corrected visual acuity < 0.5 (6/12)
Prior intraocular surgery
Allergy to atropine eye drops
Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome
History of cardiac or significant respiratory diseases
Lack of consent for participating in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hina Nadeem, MBBS	Contact	03252120568		hinanadeem1508@gmail.com

Overall Officials

Name	Affiliation	Role
Hina Nadeem, MBBS	LNHMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LiaquatNHMC	Recruiting	Karachi	Sindh		Pakistan

Intervention Browse Module

MeSH Terms

ID	Term
D001285	Atropine
D009883	Ophthalmic Solutions

Ancestor Terms

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds

Browse Leaves

Not provided

Browse Branches

Not provided