免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation

Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation

Study Description
Brief Summary:
Glaucoma, progressive optical neuropathy, is the leading cause of irreversible blindness in the world. Glaucoma treatment aims to lower intraocular pressure (IOP) by using medication, laser and surgery. Patients suffering from refractory and advanced glaucoma with impaired visual field who are not good candidates for surgery, cadenced subcleral transscleral cyclophotocoagulation (CPCTSI) is commonly used to reduce IOP. The CPCTSI consists in delivering short bursts of energy (in cycle) to the ciliary body, thus reducing production of aqueous humor. The energy gusts develop sequentially to a photocoagulating state in the pigmented epithelium. They are spaced by rest periods that allow surrounding tissue to cool down and remain below photocoagulative threshold, thus avoiding damage to surrounding tissue. Some studies have shown that the risk of complications increases with higher energies. Complications associated with CPCTSI include prolonged intraocular inflammation, pain, intraocular hemorrhage, hypotonia, phthysis, decreased vision and sympathetic ophthalmia. Severity of these complications depends on collateral damage inflicted on surrounding tissues: ciliary muscles, unpigmented epithelium and stroma of ciliary body. Currently, CPCTSI with a cycle ratio of 25% and 31.3% are used in surgical routine in ophthalmology. Cycle ratio is ratio between duration of gusts and total duration of cycle (gusts and rest periods). At St. Joseph's Hospital, both cycle ratios are used and the choice is operator dependent. However, using CPCTSI with a 25% cycle ratio could have fewer complications while maintaining similar efficacy. To our knowledge, there are no studies comparing these two cycle reports, although they are commonly used in practice. Our objective is to compare the CPCTSI with a cycle ratio of 25% and 31.3%.

Condition or disease
Glaucoma

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation With a Duty Factor of 25 % Versus 31.3 % for Advanced Glaucoma
Actual Study Start Date : October 12, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 12, 2019
Arms and Interventions
Group/Cohort
25% cycle ratio
Patients group treated with CPCTSI at a 25% cycle ratio
31.3% cycle ratio
Patients group treated with CPCTSI at a 31.3% cycle ratio
Outcome Measures
Primary Outcome Measures :
  1. Efficiency - Difference in success rates [ Time Frame: Year 1 ]
    Change in success rates between two groups of patients.


Secondary Outcome Measures :
  1. Tolerance - Differences in occurrence frequency of side effects [ Time Frame: Year 1 ]
    Changes in occurrence frequency of side effects between two groups of patients.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with refractory and advanced glaucoma
Criteria

Inclusion Criteria:

  • Patients with refractory and advanced glaucoma, defined as IOP > 21 mmHg according to maximum tolerated medical treatment, with or without pre-glaucoma surgical procedures and a visual field > 6 MD
  • Patients treated in the GHPSJ ophthalmology department by a CPCTSI with cycle ratios of 25% or 31.3% between January and July 2017
  • Patients who are poor candidates for additional filtration surgery or implantation of glaucoma drainage devices.

Exclusion Criteria:

  • Patients who underwent intraocular surgery in the 2 months prior to CPCTSI
  • Patients who have undergone conventional transscleral laser diode cyclophotocoagulation
  • Patients who object to use of their data for this research.
Contacts and Locations

Locations
Layout table for location information
France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Tracking Information
First Submitted Date May 22, 2019
First Posted Date May 23, 2019
Last Update Posted Date May 28, 2019
Actual Study Start Date October 12, 2018
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2019)
Efficiency - Difference in success rates [ Time Frame: Year 1 ]
Change in success rates between two groups of patients.
Original Primary Outcome Measures
 (submitted: May 22, 2019)
Efficiency - Difference in success rates [ Time Frame: Year 1 ]
Difference in success rates between two groups of patients.
Change History
Current Secondary Outcome Measures
 (submitted: May 23, 2019)
Tolerance - Differences in occurrence frequency of side effects [ Time Frame: Year 1 ]
Changes in occurrence frequency of side effects between two groups of patients.
Original Secondary Outcome Measures
 (submitted: May 22, 2019)
Tolerance - Differences in occurrence frequency of side effects [ Time Frame: Year 1 ]
Differences in occurrence frequency of side effects between two groups of patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation
Official Title Comparative Effectiveness and Tolerance of Subliminal Subthreshold Transscleral Cyclophotocoagulation With a Duty Factor of 25 % Versus 31.3 % for Advanced Glaucoma
Brief Summary Glaucoma, progressive optical neuropathy, is the leading cause of irreversible blindness in the world. Glaucoma treatment aims to lower intraocular pressure (IOP) by using medication, laser and surgery. Patients suffering from refractory and advanced glaucoma with impaired visual field who are not good candidates for surgery, cadenced subcleral transscleral cyclophotocoagulation (CPCTSI) is commonly used to reduce IOP. The CPCTSI consists in delivering short bursts of energy (in cycle) to the ciliary body, thus reducing production of aqueous humor. The energy gusts develop sequentially to a photocoagulating state in the pigmented epithelium. They are spaced by rest periods that allow surrounding tissue to cool down and remain below photocoagulative threshold, thus avoiding damage to surrounding tissue. Some studies have shown that the risk of complications increases with higher energies. Complications associated with CPCTSI include prolonged intraocular inflammation, pain, intraocular hemorrhage, hypotonia, phthysis, decreased vision and sympathetic ophthalmia. Severity of these complications depends on collateral damage inflicted on surrounding tissues: ciliary muscles, unpigmented epithelium and stroma of ciliary body. Currently, CPCTSI with a cycle ratio of 25% and 31.3% are used in surgical routine in ophthalmology. Cycle ratio is ratio between duration of gusts and total duration of cycle (gusts and rest periods). At St. Joseph's Hospital, both cycle ratios are used and the choice is operator dependent. However, using CPCTSI with a 25% cycle ratio could have fewer complications while maintaining similar efficacy. To our knowledge, there are no studies comparing these two cycle reports, although they are commonly used in practice. Our objective is to compare the CPCTSI with a cycle ratio of 25% and 31.3%.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with refractory and advanced glaucoma
Condition Glaucoma
Intervention Not Provided
Study Groups/Cohorts
  • 25% cycle ratio
    Patients group treated with CPCTSI at a 25% cycle ratio
  • 31.3% cycle ratio
    Patients group treated with CPCTSI at a 31.3% cycle ratio
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 22, 2019)
40
Original Actual Enrollment Same as current
Actual Study Completion Date January 12, 2019
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with refractory and advanced glaucoma, defined as IOP > 21 mmHg according to maximum tolerated medical treatment, with or without pre-glaucoma surgical procedures and a visual field > 6 MD
  • Patients treated in the GHPSJ ophthalmology department by a CPCTSI with cycle ratios of 25% or 31.3% between January and July 2017
  • Patients who are poor candidates for additional filtration surgery or implantation of glaucoma drainage devices.

Exclusion Criteria:

  • Patients who underwent intraocular surgery in the 2 months prior to CPCTSI
  • Patients who have undergone conventional transscleral laser diode cyclophotocoagulation
  • Patients who object to use of their data for this research.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03961035
Other Study ID Numbers CPCTSI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Not Provided
Investigators Not Provided
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date May 2019