A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
A legfontosabb adatok
- Ki végzi
- Massachusetts General Hospital
- Hol
- Boston (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 168 fő, tervezett
- Kezdés
- 2013. jún.
- Várható befejezés
- 2030. szept.
- A vizsgálat típusa
- Megfigyeléses, 7 csoport
- A vizsgált kezelések
- Brillouin imaging
- A regiszteradat frissítve
- 2026. október 8.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with healthy corneas, keratoconus, ectasia after LASIK, or Fuchs' corneal dystrophy, and people about to have LASIK or PRK. It tests a new imaging method of the cornea.
- Életkor
- 20 to 75 years. The group with ectasia after LASIK is 20 to 60 years.
- Nem
- All sexes can join.
- A betegség stádiuma
- Groups: healthy corneas; mild, moderate or advanced keratoconus; LASIK in the past 12 months without problems; ectasia (thinning and bulging of the cornea) at least 12 months after LASIK; short-sightedness with planned PRK or LASIK; Fuchs' corneal dystrophy at early, mild or advanced stage.
- Korábbi kezelés
- PRK and LASIK groups cannot have had earlier eye surgery. They cannot use eye medicines except seasonal allergy drops such as ketotifen or artificial tears. The Fuchs' group cannot have had eye surgery that may affect the inner cornea cells, such as cataract surgery.
A részvétel fő kizáró okai
- Narrow eye drainage angles that may close, without an open laser hole in the iris (patent peripheral iridotomy)
- Having sight in only one eye
- Not able to understand the imaging instructions
- PRK and LASIK groups: astigmatism over 2 diopter
- Fuchs' group: any other cornea disorder besides keratoconus
A regiszter feltételei, szó szerint
Mind a 5 feltétel megnézéseKevesebb
Ki vehet részt
- Group I includes healthy subjects with normal appearing corneas, normal topography and pachymetry. Group II includes patients diagnosed as having mild, moderate or advanced keratoconus by our ophthalmology expert on the basis of topography and pachymetry. Group III includes healthy subjects who have undergone LASIK surgery in the past 12 months without complications. Inclusion criteria include normal post-operative topography and pachymetry. Group IV includes patients (age 20 - 60) who have undergone LASIK surgery at least 12 months before the study imaging and have been diagnosed with post-LASIK ectasia based on topography, pachymetry and clinical evaluation.Patients diagnosed with keratoconus. Group V- Volunteers to receive PRK surgery This group includes patients who have been diagnosed with myopia and have been scheduled to undergo PRK surgery. Patients with high astigmatism > 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen or artificial tears will be excluded. Group VI-Volunteers to receive LASIK Surgery This group includes myopic patients who are scheduled to receive LASIK surgery. Patients with high astigmatism > 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen and artificial tears will be excluded. Group VII- Patients with Fuch's Endothelial Corneal Dystrophy. This group includes subjects who are diagnosed with Fuch's corneal dystrophy, at early, mild and advanced stages. The inclusion also extends to subjects with, and without keratoconus. But this exclude patients with any other corneal disorders other than keratoconus, and/or history of ophthalmological surgeries that may affect endothelium cell status, e.g. cataract surgeries
- Overall Exclusion Criteria for all groups: Volunteers who
- Have occludable narrow angles (without a patent peripheral iridotomy)
- Monocular subjects
- Do not or cannot understand the instructions for the imaging
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 20 és 75 év között vagy?
Helyszínek itt: Egyesült Államok
- Massachusetts General HospitalBoston, Egyesült ÁllamokContact: giuliano scarcelli, PhDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
We have developed novel Brillouin microscopy and we are testing its potential for keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare biomechanical properties of post-LASIK ectasia vs. normal corneas.
A vizsgálat 7 csoportja
- Healthy volunteers
Volunteers with normal corneas
Kezelés: Brillouin imaging
- Patients with keratoconus
Patients diagnosed with keratoconus
Kezelés: Brillouin imaging
- post-LASIK no complications
Subjects who underwent LASIK refractive surgery with no complications
Kezelés: Brillouin imaging
- post-LASIK who developed ectasia
patients who underwent LASIK refractive surgery and developed ectasia as a complications
Kezelés: Brillouin imaging
- Volunteers to receive PRK surgery
This group includes patients who have been diagnosed with myopia and have been scheduled to undergo PRK surgery. Patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen or artificial tears will be excluded.
Kezelés: Brillouin imaging
- Volunteers to receive LASIK Surgery
This group includes myopic patients who are scheduled to receive LASIK surgery. Patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen and artificial tears will be excluded.
Kezelés: Brillouin imaging
- Patients with Fuch's Endothelial Corneal Dystrophy
This group includes subjects who are diagnosed with Fuch's corneal dystrophy, at early, mild and advanced stages. The inclusion also extends to subjects with, and without keratoconus. But this exclude patients with any other corneal disorders other than keratoconus, and/or history of ophthalmological surgeries that may affect endothelium cell status, e.g. cataract surgeries.
Kezelés: Brillouin imaging
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
- Illeszkedési kérdések
- Forrás: NCT02118922: ki vehet részt
- A regiszteradat frissítve
- 2026. október 8.