Interval Intraocular Pressure in Intravitreal Injection Study
NCT ID: NCT04868175
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2019-10-01
2021-04-01
Brief Summary
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1. IOP effect of intravitreal injection
2. IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods
3. IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities
Detailed Description
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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:
1. 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
2. Day 1 follow-up visit
* IOP via iCare (sitting)
* Slitlamp examination, document inflammation or complications if any
3. 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
PREVENTION
DOUBLE
Study Groups
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Group 1
control (hypromellose), then Timolol, then Travatan
Timolol
Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
Travatan
Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
Hypromellose
Placebo eye drop, lubricant
Group 2
Timolol, then Travatan, Hypromellose
Timolol
Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
Travatan
Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
Hypromellose
Placebo eye drop, lubricant
Group 3
Travatan, then Hypromellose, Timolol
Timolol
Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
Travatan
Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
Hypromellose
Placebo eye drop, lubricant
Interventions
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Timolol
Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
Travatan
Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
Hypromellose
Placebo eye drop, lubricant
Eligibility Criteria
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Inclusion Criteria
* Age \>50
* Chinese patients with ability to read Chinese ICF
Exclusion Criteria
2. Corneal disease e.g. corneal scarring or opacity preventing fundal view
3. On steroid or anti glaucoma eye drops
4. Prior vitrectomy or glaucoma surgery
5. Recent intraocular surgery i.e. cataracts surgery
6. Pseudophakic with anterior chamber IOL
7. History of ocular inflammatory disease e.g. uveitis
8. Previous laser iridotomy
9. Recent intravitreal injection of steroid
10. Inability for regular follow-up
50 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Locations
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HKSDS Program
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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IIII
Identifier Type: -
Identifier Source: org_study_id