Interval Intraocular Pressure in Intravitreal Injection Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study

Conditions
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Glaucoma, Intraocular Pressure

Intervention / Treatment
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* Drug: Timolol
* Drug: Travatan
* Drug: Hypromellose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>control (hypromellose), then Timolol, then Travatan | Drug: Timolol<br>* Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production<br>Drug: Travatan<br>* Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow<br>Drug: Hypromellose<br>* Placebo eye drop, lubricant<br>|
| Active Comparator: Group 2<br>Timolol, then Travatan, Hypromellose | Drug: Timolol<br>* Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production<br>Drug: Travatan<br>* Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow<br>Drug: Hypromellose<br>* Placebo eye drop, lubricant<br>|
| Active Comparator: Group 3<br>Travatan, then Hypromellose, Timolol | Drug: Timolol<br>* Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production<br>Drug: Travatan<br>* Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow<br>Drug: Hypromellose<br>* Placebo eye drop, lubricant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP effect of prophylactic IOP lowering eye drops over multiple time points | IOP in mmHg | From baseline to 30 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP effect of intravitreal injection | IOP in mmHg | From baseline to 30 minutes after injection | 
| IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities | IOP in mmHg | From baseline to 30 minutes after injection | 
| Inflammation to types of anti VEGF | presence of inflammation | 1 week post injection |