Tonometria ad applanazione automatizzata - Aggiornato
Goldmann Applanation Tonometry (GAT) is considered the clinical gold standard for eye pressure measurements and yet it is known to be a subjective measurement with limited repeatability and limited portability. Another clinical standard for checking eye pressure is known as the pneumotonometer. This method is more objective but not portable. The purpose of this study is to develop new methods of measuring eye pressure that are more objective, reproducible and portable. In this study, the investigators will be comparing the eye pressure measurements using 2 investigational methods to GAT and pneuumotonometer.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This is a prospective study. Patients presenting for their scheduled eye appointments will be recruited by verbal communication. Following informed consent, intraocular pressure (IOP) measurements will be made by the following methods:
Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice. The eye is given topical fluorescein/anesthetic, the GAT prism contacts the eye while the observer looks through the slit lamp machine ocular using blue light illumination to visual the applanation mires. The GAT dial is adjusted until mire alignment is achieved and the IOP measurement is read off the GAT dial.
Pneumotonometer: This is what is done in routine eye care. The participant will receive a topical anesthetic (numbing agent). A probe will touch the front of the eye while the machine measures the eye pressure.
Fixed force GAT: From the patient perspective, this method will feel identical to the standard GAT. The eye is given topical fluorescein/anesthetic. The GAT dial is set at 1.8 or 2.0, a complementary metal oxide semiconductor (C-MOS) camera is connected to one of the oculars of the slit lamp machine and under blue light illumination, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance through the ocular. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter. A similar method using an iPod touch camera has been previously published by this PI.
Upright applanating prototype: With this prototype, an applanating prism (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is attached to a fixed-force spring that creates a force equivalent to 1.8 or 2.0 on the GAT dial. Blue LED lights on the prototype are used to create the blue illumination similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. A C-MOS camera is aligned with the GAT prism to image the applanation mires. The eye is given topical fluorescein/anesthetic. Like fixed-force GAT, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter.
The order of the above 4 measurements will be randomized.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sarah Jones
- Numero di telefono: 919 681 6584
- Email: sarah.jones1@duke.edu
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Reclutamento
- Duke Eye Center
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Investigatore principale:
- Joanne Wen, MD
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Contatto:
- Joanne Wen, MD
- Numero di telefono: +1 919 684 2975
- Email: joanne.wen@duke.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Criteria:
Inclusion Criteria:
- Presenting for a routine eye exam
- ≥ 18 years of age
- Able and willing to give consent
Exclusion Criteria:
- History of corneal scarring
- Active infection of the eye
- Ocular surface trauma or infection
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Standard GAT
This is the gold-standard method for IOP measurement in clinical practice |
Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice |
|
Sperimentale: Fixed-force GAT
From the patient perspective, this method will feel identical to the standard GAT. The eye is given topical fluorescein/anesthetic. The GAT dial is set at 1.8 or 2.0, a C-MOS camera is connected to one of the oculars of the slit lamp machine and under blue light illumination, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance through the ocular. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter |
An investigational device similar to standard GAT |
|
Sperimentale: Upright applanating prototype
With this prototype, an applanating prism (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is attached to a fixed-force spring that creates a force equivalent to 1.8 or 2.0 on the GAT dial. Blue LED lights on the prototype are used to create the blue illumination similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. A C-MOS camera is aligned with the GAT prism to image the applanation mires. The eye is given topical fluorescein/anesthetic. Like fixed-force GAT, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter |
An investigational device, prism used in standard and fixed-force GAT is attached to a portable device |
|
Comparatore attivo: Pneumotonometer
This is another standard method for IOP measurement in clinical practice |
This is a standard for checking eye pressure. A topical anesthetic (numbing agent). A probe will touch the front of the eye while the machine measures the eye pressure |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pressione intraoculare misurata con pneumotonometro in posizione supina
Lasso di tempo: Baseline
|
Baseline
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Intraocular pressure (IOP) as measured by standard GAT
Lasso di tempo: Baseline
|
this is the standard method for IOP measurement in clinical practice. The eye is given topical fluorescein/anesthetic, the GAT prism contacts the eye while the observer looks through the slit lamp machine ocular using blue light illumination to visual the applanation mires. The GAT dial is adjusted until mire alignment is achieved and the IOP measurement is read off the GAT dial. |
Baseline
|
|
Intraocular pressure (IOP) as measured by fixed force GAT
Lasso di tempo: Baseline
|
From the patient perspective, this method will feel identical to the standard GAT. The eye is given topical fluorescein/anesthetic. The GAT dial is set at 1.8 or 2.0, a C-MOS camera is connected to one of the oculars of the slit lamp machine and under blue light illumination, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance through the ocular. |
Baseline
|
|
Intraocular pressure as measured by upright applanating
Lasso di tempo: Baseline
|
With this prototype, an applanating prism (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is attached to a fixed-force spring that creates a force equivalent to 1.8 or 2.0 on the GAT dial. Blue LED lights on the prototype are used to create the blue illumination similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. A C-MOS camera is aligned with the GAT prism to image the applanation mires. The eye is given topical fluorescein/anesthetic. Like fixed-force GAT, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter. |
Baseline
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Joanne Wen, MD, Duke Eye Center
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Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00106111_1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
No Currently, there is no plan to share data with other researchers.
Informazioni su farmaci e dispositivi, documenti di studio
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