Error, RefractiveNCT04816266
Comparative Study in Measuring Anterior Chamber Depth
An observational study of Error, Refractive, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Error, Refractive
- What is being tested?
- Iol master and Pentacam
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Adult
Study population: People between eighteen and forty years seeking for refractive surgery
Who may be able to join
- presenting for glasses
- asking for refractive surgery
Who cannot join
- severe corneal scarring or opacity
- patients with corneal dystrophy
- patients with keratoconus
- patients with previous ocular surgery
- patients with ocular trauma
- patients with uveitis
About this study
Official title: Comparative Study Between Pentacam and IOL Master in Measuring Anterior Chamber Depth
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
Read the detailed description
IOL master :
Optical biometry by the IOL Master was introduced in the United Kingdom in 1999.Its technology is based on laser interfer-ometry with partial coherent light, termed as Partial Coherence Interferometry (PCI).The device uses the principle of PCI to measure the axial length of the eye.While uses a slit-beam photo-graphic technique for ACD measurements For keratometry measurement, six light spots are projected hexagonally on the cornea .The device records the reflection of these images measuring the separation of the opposite pairs of light spots and calculating the corneal radii and toroidal surface curvature. The mean of the taken measurements is considered the corneal power . The displayed K1 and K2 represent the average keratometry values at two major perpendicular meridians .For ACD measurement, the IOL Master directs a slit beam of light 0.7mm wide through the anterior segment at an angle of 38º to the visual axis.The internal software measures the distance between anterior pole of the cornea and the anterior surface of the lens to calculate the ACD . The device takes five ACD measurements in rapid succession; the mean of these readings are taken as the ACD value . For WTW measurement, a digital grey-scale photograph of the anterior surface of the eye is taken after focusing on the iris. The limbus is then detected automatically and the WTW distance is measured
Pentacam :
The Pentacam obtains images of the anterior segment by a rotating Scheimpflug blue Light Emitting Diode (LED) with a wavelength of 475nm. It acquires 50 images in a duration of approximately two seconds. It extracts about 2,760 true elevation points from the obtained images which in turn generates 1 38,000 true elevation points for the both front and back corneal surfacesand from limbus to limbus, including the central part of the cornea . There for, it calculates k-readings of the cornea. The Pentacam HR calculates ACD from the corneal endothelial layer along a line from the apex of the cornea to the anterior surface of the lens . Horizontal WTW was measured by manual placement of callipers on the Scheimpflug image of the horizontal plane of the examined eye; callipers are placed on the corneo-scleral junction then a line is automat-ically drawn between the two points . The length of this line represents the WTW value
- Conditions
- Error, Refractive
- Being tested
- Iol master, Pentacam
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iol masterDevice
Iol master measures the distance between anterior pole of the cornea and the anterior surface of the lens to calculate the anterior chamber depth
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
| Study group | Role | What they receive |
|---|---|---|
| Myopic patients | Not described Receives: Device: Iol master; Device: Pentacam | |
| Hypermetropic patients | Not described Receives: Device: Iol master; Device: Pentacam | |
| Emmetropic people | Not described Receives: Device: Iol master; Device: Pentacam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Error, RefractiveStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Adel Fayez Demian, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816266
- Sponsor's protocol ID
- Anterior chamber depth
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Pentacam and IOL Master in Measuring Anterior Chamber Depth
- ClinicalTrials.gov ID
- NCT04816266
- Acronym / sponsor ID
- Anterior chamber depth
- Conditions
- Error, Refractive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
IOL master :
Optical biometry by the IOL Master was introduced in the United Kingdom in 1999.Its technology is based on laser interfer-ometry with partial coherent light, termed as Partial Coherence Interferometry (PCI).The device uses the principle of PCI to measure the axial length of the eye.While uses a slit-beam photo-graphic technique for ACD measurements For keratometry measurement, six light spots are projected hexagonally on the cornea .The device records the reflection of these images measuring the separation of the opposite pairs of light spots and calculating the corneal radii and toroidal surface curvature. The mean of the taken measurements is considered the corneal power . The displayed K1 and K2 represent the average keratometry values at two major perpendicular meridians .For ACD measurement, the IOL Master directs a slit beam of light 0.7mm wide through the anterior segment at an angle of 38º to the visual axis.The internal software measures the distance between anterior pole of the cornea and the anterior surface of the lens to calculate the ACD . The device takes five ACD measurements in rapid succession; the mean of these readings are taken as the ACD value . For WTW measurement, a digital grey-scale photograph of the anterior surface of the eye is taken after focusing on the iris. The limbus is then detected automatically and the WTW distance is measured
Pentacam :
The Pentacam obtains images of the anterior segment by a rotating Scheimpflug blue Light Emitting Diode (LED) with a wavelength of 475nm. It acquires 50 images in a duration of approximately two seconds. It extracts about 2,760 true elevation points from the obtained images which in turn generates 1 38,000 true elevation points for the both front and back corneal surfacesand from limbus to limbus, including the central part of the cornea . There for, it calculates k-readings of the cornea. The Pentacam HR calculates ACD from the corneal endothelial layer along a line from the apex of the cornea to the anterior surface of the lens . Horizontal WTW was measured by manual placement of callipers on the Scheimpflug image of the horizontal plane of the examined eye; callipers are placed on the corneo-scleral junction then a line is automat-ically drawn between the two points . The length of this line represents the WTW value
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myopic patients | – | Device: Iol master, Device: Pentacam |
| Hypermetropic patients | – | Device: Iol master, Device: Pentacam |
| Emmetropic people | – | Device: Iol master, Device: Pentacam |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- People between eighteen and forty years seeking for refractive surgery
Key inclusion criteria (2 listed)
- presenting for glasses
- asking for refractive surgery
Key exclusion criteria (6 listed)
- severe corneal scarring or opacity
- patients with corneal dystrophy
- patients with keratoconus
- patients with previous ocular surgery
- patients with ocular trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iol masterIol master measures the distance between anterior pole of the cornea and the anterior surface of the lens to calculate the anterior chamber depth | Device | Emmetropic people, Hypermetropic patients, Myopic patients |
| PentacamThe 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 | Device | Emmetropic people, Hypermetropic patients, Myopic patients |
Primary outcome
Comparison between values of anterior chamber depth obtained by different devices
Time frame: One year
Measuring Anterior chamber depth by Pentacam and iol master in eyes with different refractive errors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Error, Refractive, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between values of anterior chamber depth obtained by different devices (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.