Interval Intraocular Pressure in Intravitreal Injection Study (IIII)
Primary Purpose
Glaucoma, Intraocular Pressure
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Timolol
Travatan
Hypromellose
Sponsored by
About this trial
This is an interventional prevention trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
- Age >50
- Chinese patients with ability to read Chinese ICF
Exclusion Criteria:
- Known glaucoma
- Corneal disease e.g. corneal scarring or opacity preventing fundal view
- On steroid or anti glaucoma eye drops
- Prior vitrectomy or glaucoma surgery
- Recent intraocular surgery i.e. cataracts surgery
- Pseudophakic with anterior chamber IOL
- History of ocular inflammatory disease e.g. uveitis
- Previous laser iridotomy
- Recent intravitreal injection of steroid
- Inability for regular follow-up
Sites / Locations
- HKSDS Program
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
control (hypromellose), then Timolol, then Travatan
Timolol, then Travatan, Hypromellose
Travatan, then Hypromellose, Timolol
Outcomes
Primary Outcome Measures
IOP effect of prophylactic IOP lowering eye drops over multiple time points
IOP in mmHg
Secondary Outcome Measures
IOP effect of intravitreal injection
IOP in mmHg
IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities
IOP in mmHg
Inflammation to types of anti VEGF
presence of inflammation
Full Information
NCT ID
NCT04868175
First Posted
April 20, 2021
Last Updated
April 27, 2021
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04868175
Brief Title
Interval Intraocular Pressure in Intravitreal Injection Study
Acronym
IIII
Official Title
The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective study of IOP in Intravitreal injections to evaluate:
IOP effect of intravitreal injection
IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods
IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities
Detailed Description
Study design: A prospective study Sample size: 60 patients (180 readings) Recruitment: Patients will be recruited at the intravitreal injection clinic in Grantham Hospital.
Randomization:
Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol
There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly.
Injection doctors masked to treatments given.
Study visits:
Injection visit
Record the anti-VFGF injection to be given
Macula disease involved
Record no. of previous injections
Prophylactic eye drops will be given according to treatment group 1 hour prior injection
IOP immediately before injection (without speculum while sitting on table)
IOP immediately after injection (without speculum while sitting on table)
IOP 30 minutes after injection via iCare
Slitlamp examination, document inflammation or complications if any
Day 1 follow-up visit
IOP via iCare (sitting)
Slitlamp examination, document inflammation or complications if any
Week 1 follow-up visit
IOP via iCare (sitting)
Slitlamp examination, document inflammation or complications if any Visit a, b and c will be repeated for 2nd and 3rd injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Intraocular Pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol
There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly.
Injection doctors masked to treatments given.
Masking
ParticipantCare Provider
Masking Description
Patients are not exposed to the eye drop bottle (taped) and the doctors measuring pressure and performing the intravitreal injections are not shown the eye drops given
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
control (hypromellose), then Timolol, then Travatan
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Timolol, then Travatan, Hypromellose
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Travatan, then Hypromellose, Timolol
Intervention Type
Drug
Intervention Name(s)
Timolol
Intervention Description
Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
Intervention Type
Drug
Intervention Name(s)
Travatan
Intervention Description
Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
Intervention Type
Drug
Intervention Name(s)
Hypromellose
Intervention Description
Placebo eye drop, lubricant
Primary Outcome Measure Information:
Title
IOP effect of prophylactic IOP lowering eye drops over multiple time points
Description
IOP in mmHg
Time Frame
From baseline to 30 minutes after injection
Secondary Outcome Measure Information:
Title
IOP effect of intravitreal injection
Description
IOP in mmHg
Time Frame
From baseline to 30 minutes after injection
Title
IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities
Description
IOP in mmHg
Time Frame
From baseline to 30 minutes after injection
Title
Inflammation to types of anti VEGF
Description
presence of inflammation
Time Frame
1 week post injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
Age >50
Chinese patients with ability to read Chinese ICF
Exclusion Criteria:
Known glaucoma
Corneal disease e.g. corneal scarring or opacity preventing fundal view
On steroid or anti glaucoma eye drops
Prior vitrectomy or glaucoma surgery
Recent intraocular surgery i.e. cataracts surgery
Pseudophakic with anterior chamber IOL
History of ocular inflammatory disease e.g. uveitis
Previous laser iridotomy
Recent intravitreal injection of steroid
Inability for regular follow-up
Facility Information:
Facility Name
HKSDS Program
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Interval Intraocular Pressure in Intravitreal Injection Study
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