Clinical trials: Surgical Errors
Astigmatism
Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions
This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.
- Trial name
- NCT02164994
- Where
- Czechia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Technolas Perfect Vision GmbH
Myopic Astigmatism
A Study to Investigate the Safety and Effectiveness of the Technolas® TENEO 317 Model 2 Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Myopia or Myopic Astigmatism
This will be a multicenter, prospective, open label, non-randomized, single arm study evaluating the safety and effectiveness of the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser when used in LASIK surgery…
- Trial name
- NCT07377474
- Testing
- TENEO 317 Model 2 (1.28 US) Excimer Laser
- Volunteers
- 32 people
- Sponsor
- Bausch & Lomb Incorporated
Astigmatism
A Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery
The purpose of this open, prospective study is to address the effectiveness and precision of the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after femtolaser-assisted cataract surgery.
- Trial name
- NCT01752218
- Testing
- arcuate incision
- Where
- Germany
- Volunteers
- 43 people
- Sponsor
- Technolas Perfect Vision GmbH
Cataract
Postmarket Study of an Intraocular Lens Power Selection System
The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects…
- Trial name
- NCT03579433
- Testing
- ORA with VerifEye+, Alcon Barrett Toric Calculator, Acrysof® IQ Toric IOL
- Where
- 9 sites in United States
- Volunteers
- 124 people
- Sponsor
- Alcon Research
Mucopolysaccharidosis (MPS)
Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)
Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of…
- Trial name
- NCT02095015
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 159 people
- Sponsor
- Shire
Cataract, Corneal Astigmatism
ClarVista HARMONI Toric Trial With Intraoperative Exchange
The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.
- Conditions
- Cataract, Corneal Astigmatism, Aphakia
- Trial name
- NCT03054649
- Testing
- HARMONI® Modular Intraocular Lens System, Intraoperative optic exchange
- Where
- 2 sites in Mexico, Philippines
- Volunteers
- 44 people
- Sponsor
- ClarVista Medical
Refractive Errors
Early Feasibility Study to Evaluate the AccuraSee in Correcting Residual Refractive Errors After Cataract Surgery
To determine if the intraocular pseudophakic contact lens (IOPCL), referred to as the AccuraSee, corrects residual refractive errors after cataract surgery using a plus powered lens in subjects with ocular pathology previously…
- Trial name
- NCT05113979
- Testing
- AccuraSee IOPCL with +3.0D add
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- OnPoint Vision Inc
Refractive Error, Glaucoma
A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
- Conditions
- Refractive Error, Glaucoma, Cataracts, Clear Lens Exchange
- Trial name
- NCT05394324
- Testing
- Intervention
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 1,674 people
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
Hyperopia
Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism
This will be a multicenter, prospective, open label, non-randomized, single arm 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in…
- Trial name
- NCT05264623
- Testing
- TENEO 317 Model 2 excimer laser
- Where
- 9 sites in United States
- Volunteers
- 140 people
- Sponsor
- Bausch & Lomb Incorporated
Aphakia, Presbyopia
Contralateral Claims Study of Clareon Vivity Pro
The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.
- Trial name
- NCT07484191
- Testing
- Clareon Vivity Pro IOL, Clareon Vivity IOL, TECNIS PureSee IOL
- Where
- 7 sites in Australia
- Volunteers
- 165 people
- Sponsor
- Alcon Research
Mixed Astigmatism
Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Mixed Astigmatism
The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of mixed astigmatism up to 6.0 D, when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.
- Trial name
- NCT00761826
- Testing
- MEL 80 Mixed Astigmatism Treatment
- Where
- 5 sites in United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Carl Zeiss Meditec, Inc.
Cataract, Presbyopia
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
- Trial name
- PSM15 (NCT02838004)
- Testing
- IOL MINI WELL READY
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- SIFI SpA
Hyperopia
5 Year Follow up of SMILE® Procedure for the Correction of Hyperopia
The planned study will investigate and evaluate refractive stability, predictability, and safety in patients who underwent SMILE® pro surgery for hyperopia with or without astigmatism at least five years ago.
- Trial name
- PHOBOS-5FU (NCT07133737)
- Where
- 2 sites in Czechia, Germany
- Volunteers
- 100 people
- Sponsor
- Gemini Eye Clinic
Myopia, Hyperopia
Creating LASIK Flaps With the LenSx Femtosecond Laser
This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.
- Trial name
- NCT01556893
- Testing
- LenSx Laser
- Where
- Hungary
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Alcon LenSx, Inc.
Astigmatism
Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism
The investigational enVista IOL, Model MX60Tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism.
- Trial name
- NCT01852084
- Testing
- enVista® One-Piece Hydrophobic Acrylic Toric IOL, enVista control lens
- Where
- United States
- Volunteers
- 191 people
- Sponsor
- Bausch & Lomb Incorporated
Refractive Error
Evaluation of a Surgical Microscope Mounted Autorefractor When Used on Patients Lying in a Supine Position
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope.
- Trial name
- NCT01827748
- Testing
- Intraoperative Autorefractor IAR-1, Hartmann-Shack Auto Refractor
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Adventus Technology
Cataract, Astigmatism
Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts.
- Trial name
- ARCUATAS (NCT05053620)
- Testing
- Calculation of the arcuate intrasomal incisions
- Where
- Spain
- Volunteers
- 22 people
- Sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
Aphakia, Presbyopia
Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs
The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes.
- Trial name
- NCT07161635
- Testing
- Clareon PanOptix Pro/Pro Toric Trifocal IOL, Phacoemulsification
- Where
- 5 sites in United States
- Volunteers
- 110 people
- Sponsor
- Alcon Research
Astigmatism
Evaluation of Visual Acuity of the Envista One-piece Acrylic Toric IOL MX60ET
The primary objective of this study is to evaluate rotational stability and functional improvements in visual acuity of the enVista monofocal Toric IOL (MX60ET) following cataract surgery.
- Trial name
- NCT05739656
- Testing
- CATARACT SURGERY
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Bausch & Lomb Incorporated
Myopia
Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Moderate to High Myopia
The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of moderate to high myopia (nearsightedness), when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.
- Trial name
- NCT00762541
- Testing
- MEL 80 Treatment of High Myopia
- Where
- 5 sites in United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Carl Zeiss Meditec, Inc.