NCT05670015

Brief Summary

selective alpha-2 receptor agonists cause changes in intraocular pressure and pupillary size thus may affect patient quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

January 2, 2023

Last Update Submit

January 2, 2023

Conditions

Glaucoma, SuspectAberration, Corneal Wavefront

Keywords

Glaucoma suspectPost-lasik

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    Changes in intraocular pressure measured in mmHg by applanation tonometry

    Baseline and 6 months after regular use of the topical eyedrops

Secondary Outcomes (1)

  • Pupillary diameter

    Baseline and 6 months after regular use of the topical eyedrops

Study Arms (2)

Glaucoma suspect group

ACTIVE COMPARATOR

Cases diagnosed as glaucoma suspect

Drug: Low dosage selective alpha-2 receptor agonists topical eyedropDrug: High dosage selective alpha-2 receptor agonists topical eyedrop

Post-refractive surgery group

ACTIVE COMPARATOR

Cases had undergone refractive surgery

Drug: Low dosage selective alpha-2 receptor agonists topical eyedropDrug: High dosage selective alpha-2 receptor agonists topical eyedrop

Interventions

Low dosage selective alpha-2 receptor agonists topical eyedropDRUG

Using selective alpha-2 receptor agonists eyedrop in both groups with 0.2% concentration.

Also known as: Topical selective alpha-2 receptor agonists
Glaucoma suspect groupPost-refractive surgery group
High dosage selective alpha-2 receptor agonists topical eyedropDRUG

Using selective alpha-2 receptor agonists eyedrop in both groups with 0.02% concentration.

Also known as: Topical selective alpha-2 receptor agonists
Glaucoma suspect groupPost-refractive surgery group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Glaucoma suspect cases.
  • post-refractive surgery cases.

You may not qualify if:

  • Cases with prostatic hyperplasia or diabetics that may alter the measurements of pupillary diameter.
  • Cases with previous history of any retinal intervention or other drugs that may alter intraocular pressure measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy

Banhā, QA, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Ocular HypertensionCorneal Wavefront Aberration

Condition Hierarchy (Ancestors)

Eye DiseasesCorneal DiseasesRefractive Errors

Study Officials

  • Ahmed A Abdelshafy, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

01222328766ahmad4lg@gmail.com

Marwa Abdelshafy, MD

CONTACT

01008128810drmarwatabl2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ophthalmology

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

January 1, 2023

Primary Completion

August 10, 2023

Study Completion

September 22, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)