Glaucoma, Intraocular Pressure
Conditions
Brief summary
This is a prospective study of IOP in Intravitreal injections to evaluate: 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
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: 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.
Interventions
DRUGTimolol
Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
DRUGTravatan
Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
DRUGHypromellose
Placebo eye drop, lubricant
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
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
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
1. Known glaucoma 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP effect of prophylactic IOP lowering eye drops over multiple time points | From baseline to 30 minutes after injection | IOP in mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP effect of intravitreal injection | From baseline to 30 minutes after injection | IOP in mmHg |
| IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities | From baseline to 30 minutes after injection | IOP in mmHg |
| Inflammation to types of anti VEGF | 1 week post injection | presence of inflammation |
Countries
Hong Kong
Outcome results
None listed