NCT04816266

Brief Summary

Measuring parameters of anterior segment of the eye accurately is important for diagnosing variety of diseases and for cataract surgeries, glaucoma, refractive surgeries and post-operative follow-up. One of the anterior segment parameters is the anterior chamber depth. The anterior chamber depth (ACD) measurement provides valuable information in different fields in ophthalmology. Firstly, it is important for the new theoretical biometric formulas used to calculate the power of intraocular lenses (IOLs) .Secondly, phakic IOL implantation requires precise ACD measurement for both surgical planning and IOL power calculation. Thirdly, the ACD is also implicated as a screening risk factor for glaucoma. Additionally, precise ACD measurement is thought to be important to the accurate determination of the optic zone ablation diameter for keratorefractive surgery, as well as for the analysis of postoperative ACD changes. Different technologies are used in measurement of the anterior chamber depth Such as pentacam and iol maste

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

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

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 23, 2021

Last Update Submit

March 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison between values of anterior chamber depth obtained by different devices

    Measuring Anterior chamber depth by Pentacam and iol master in eyes with different refractive errors

    One year

Study Arms (3)

Myopic patients

Device: Iol masterDevice: Pentacam

Hypermetropic patients

Device: Iol masterDevice: Pentacam

Emmetropic people

Device: Iol masterDevice: Pentacam

Interventions

Iol master measures the distance between anterior pole of the cornea and the anterior surface of the lens to calculate the anterior chamber depth

Emmetropic peopleHypermetropic patientsMyopic patients
PentacamDEVICE

The Pentacam HR calculates Anterior chamber depth from the corneal endothelial layer along a line from the apex of the cornea to the anterior surface of the lens

Emmetropic peopleHypermetropic patientsMyopic patients

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People between eighteen and forty years seeking for refractive surgery

You may qualify if:

  • presenting for glasses
  • asking for refractive surgery

You may not qualify if:

  • severe corneal scarring or opacity
  • patients with corneal dystrophy
  • patients with keratoconus
  • patients with previous ocular surgery
  • patients with ocular trauma
  • patients with uveitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2023

Last Updated

March 25, 2021

Record last verified: 2021-03