Clinical Trials Directory

Trials / Completed

CompletedNCT04868175

Interval Intraocular Pressure in Intravitreal Injection Study

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTimololTopical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
DRUGTravatanTopical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
DRUGHypromellosePlacebo eye drop, lubricant

Timeline

Start date
2019-10-01
Primary completion
2021-03-01
Completion
2021-04-01
First posted
2021-04-30
Last updated
2021-04-30

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT04868175. Inclusion in this directory is not an endorsement.