Interval Intraocular Pressure in Intravitreal Injection Study

The University of Hong Kong64 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Glaucoma Intraocular Pressure

Interventions

TimololDRUG

Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production

TravatanDRUG

Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow

HypromelloseDRUG

Placebo eye drop, lubricant

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

HKSDS Program

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

IOP effect of prophylactic IOP lowering eye drops over multiple time points

IOP in mmHg

Time frame: From baseline to 30 minutes after injection

Secondary Outcomes

IOP effect of intravitreal injection

IOP in mmHg

Time frame: 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

Time frame: From baseline to 30 minutes after injection

Inflammation to types of anti VEGF

presence of inflammation

Time frame: 1 week post injection

Data from ClinicalTrials.gov

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