Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607821115847 Date of Registration: 23/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing intraocular pressure spikes following intravitreal anti-VEGF injection with and without paracentesis.
Official scientific title Comparative study of intraocular pressure spikes following intravitreal anti-vascular endothelial growth factor injections with and without paracentesis in patients attending eyeclinic, Lagos state university teaching hospital, Ikeja, Lagos.
Brief summary describing the background and objectives of the trial Angiogenesis mediated by vascular endothelial growth factors (VEGF) plays a significant role in the physiological functions of tissues and in the pathological processes of diseases such as neovascularization, cancer, and inflammation. Anti-vascular endothelial growth factor (anti-VEGF) or anti-angiogenic agents can mitigate against the effects of the angiogenic process of VEGF. There have been a few serious adverse events reported following intravitreal injections of anti-VEGFs. Of particular concern is the intraocular pressure (IOP) spikes, which can further increase the risk of glaucoma. Paracentesis is one of the methods that is a well-established, safe, and cost-effective procedure to reduce intraocular pressure (IOP) spikes. Objectives of the study are to measure and compare immediate post-injection intraocular pressure changes in eyes receiving intravitreal anti-VEGF injections with and without paracentesis, assess the duration and extent of IOP normalization following both procedures, evaluate for any procedure-related complications associated with paracentesis and to determine whether routine paracentesis confers significant clinical benefit in preventing post-injection IOP spikes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 19/06/2026
Actual trial start date
Anticipated date of last follow up 18/06/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Paracentesis Once 5 seconds An anterior chamber paracentesis will be done using the 30-gauge needle attached to the insulin syringe to puncture the clear cornea temporally, anterior to the limbus (9 o’clock for the right eye and 3 o’clock for the left eye), parallel to the iris plane, after the intravitreal anti-VEGF injection, for those in Paracentesis group. Egress of aqueous will be observed for about 5 seconds. 31
Control Group Without Paracentesis Not Applicable Not Applicable Following instillation of topical anesthesia using amethocaine (4 mg/ml) applied three times, 5 minutes apart, patients will be sterilely prepped, with insertion of a lid speculum, and 5% povidone iodine flush, followed by a rinse with balanced salt solution. Injections of 0.05 ml of the anti-VEGF as prescribed by the retinal specialist will be done using a superotemporal or infratemporal approach at a distance of 3.5–4.0 mm away from the limbus with a 30-gauge needle. After this procedure, the injection site will be occluded for about 5 seconds with a sterile cotton-tipped applicator as the needle is withdrawn from the eye. Additional instillation of 5% povidone iodine and fourth-generation fluoroquinolone drops will be performed. After each injection, the patients will be instructed to use antibiotic drops 4 times daily for 5 days. 31 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients who have been confirmed to have retinal diseases requiring Anti-VEGF (Irrespective of the number of times received) • Those who attend the Ophthalmology clinic of LASUTH • 18 years and above • Consent to participate in the study. • Previous history of ocular surgeries (other than cataract surgery) • Aged <18 years • Corneal opacity occluding posterior segment examination • Had an intravitreal injection of corticosteroids in the last 6 months • Glaucoma patients • Prophylactic anti-glaucoma eyedrops during the perioperative period • Baseline IOP ≥ 21 mmHg • Refusal to consent 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/06/2026 LASUTH Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Ikeja 21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Impact of Intravitreal Anti-VEGF on Intraocular pressure 5minutes, 15minutes, 30minutes, 1hour and 1day post op
Secondary Outcome Impact of Paracentesis on the Intraocular Pressure 5 minutes, 15 minutes, 30 minutes, 1 hour and 1 day post op
Secondary Outcome Adverse effects of paracentesis 5 minutes, 15 minutes, 30 minutes, 1 hour and 1 day post op
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos state University Teaching Hospital 1-5 Oba Akinjobi Ikeja 21005 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Esele Chidirim 1-5 Oba Akinjobi Ikeja 21005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Esele Chidirim 1-5 Oba Akinjobi Way Ikeja 21005 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidirim Esele chidirime@gmail.com +2348161105827 1-5 Oba Akinjobi WAy
City Postal code Country Position/Affiliation
Ikeja 21005 Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries Chidirim Esele chidirime@gmail.com +2348161105827 1-5, Oba Akinjobi Way
City Postal code Country Position/Affiliation
Ikeja 21005 Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Chibuzo Ekumankama chibuzo.ekumankama@gmail.com +2348035874403 1-5 Oba Akinjobi way
City Postal code Country Position/Affiliation
Ikeja 21005 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data will shared upon requests by researchers. Statistical Analysis Plan,Study Protocol 6- 36 months after publishing manuscript. Data will be made available to researchers with approved proposal and sound methodology upon requests.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 15/07/2026 Correction made. COMPARATIVE STUDY OF INTRAOCULAR PRESSURE SPIKES FOLLOWING INTRAVITREAL ANTI - VASCULAR ENDOTHELIAL GROWTH FACTOR INJECTIONS WITH AND WITHOUT PARACENTESIS IN PATIENTS ATTENDING EYECLINIC, LAGOS STATE UNIVERSITY TEACHING HOSPITAL, IKEJA, LAGOS Comparative study of intraocular pressure spikes following intravitreal anti-vascular endothelial growth factor injections with and without paracentesis in patients attending eyeclinic, Lagos state university teaching hospital, Ikeja, Lagos.
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 03/07/2026 Correction Self Sponsored, 1-5 Oba Akinjobi, Ikeja, 21005, Nigeria, Self Funded, Esele Chidirim , 1-5 Oba Akinjobi, Ikeja, 21005, Nigeria, Self Funded,