A feasibility study of different types of laser to treat glaucoma in Nigeria

Laser treatment for glaucoma in Nigeria: a feasibility study of four different treatment modalities to provide data to design randomised controlled trials

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN25405808

Enrollment

480

Registered

2021-03-11

Start date

2021-04-14

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Eye Diseases Glaucoma

Interventions

The researcher plan to use an online website to perform the randomisation (Sealedenvelope, https://www.sealedenvelope.com) in real time for each patient. All patients recruited to the study will be r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Diagnosis of primary open-angle glaucoma (ISGEO category 1 & 2)(41) or Disc Damage Likelihood Scale (DDLS) grades 5-10 3. IOP >21 mmHg with or without glaucoma medication 4. Visual acuity better than 3/60 in eye(s) to be treated 5. Patient lives within 200 km of the hospital, for ease of follow up

Exclusion criteria

Exclusion criteria: 1. Visual acuity =3/60 due to glaucoma or other ocular pathology 2. DDLS <5 3. History of glaucoma surgery or laser 4. Evidence or history of uveitis, trauma or neovascularisation, aphakia 5. Opaque cornea 6. Angle grading <Shaffer 2 7. Patient unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Success defined as intraocular pressure (IOP) at or below target (21 mmHg) on no IOP-lowering medication (complete success) or IOP at target on one or more medication (qualified success), measured at 1 year	—

Secondary

Measure	Time frame
Clinical: 1. Change in IOP (mmHg) at 12 months as a percentage of baseline IOP levels, measured using an Icare tonometer 2. Complications following the first, and subsequent laser treatment if needed, measured by a list and frequency of complications for each laser type after treatment or at follow up points: 1 week, 1, 2, 6 and 12 months 3. Number of individuals requiring repeat laser for each laser type expressed as a percentage, measured using records of repeat treatments at the end of the study 4. Pain score subjectively measured on a scale of 1-5 where 1 = pain and 5 = extreme pain, recorded immediately after each treatment 5. Visual loss (reduction of VA to <3/60 Snellen equivalent), attributable to glaucoma progression or other causes measured at 12 months Non-clinical: 1. Recruitment rates: the proportion of eligible patients who consent to take part measured at the end of the study 2. Uptake of first and (where indicated) second or third laser treatments: the proportion of eligible patients who agreed to have the laser treatment measured at the end of the study 3. Follow up rates: the proportion of patients who return for follow up at 12 months 4. Patient-reported outcome measures (POEM) measured using a standard POEM questionnaire at 1 week after the first treatment	—

Measure

Time frame

Clinical: 1. Change in IOP (mmHg) at 12 months as a percentage of baseline IOP levels, measured using an Icare tonometer 2. Complications following the first, and subsequent laser treatment if needed, measured by a list and frequency of complications for each laser type after treatment or at follow up points: 1 week, 1, 2, 6 and 12 months 3. Number of individuals requiring repeat laser for each laser type expressed as a percentage, measured using records of repeat treatments at the end of the study 4. Pain score subjectively measured on a scale of 1-5 where 1 = pain and 5 = extreme pain, recorded immediately after each treatment 5. Visual loss (reduction of VA to <3/60 Snellen equivalent), attributable to glaucoma progression or other causes measured at 12 months Non-clinical: 1. Recruitment rates: the proportion of eligible patients who consent to take part measured at the end of the study 2. Uptake of first and (where indicated) second or third laser treatments: the proportion of eligible patients who agreed to have the laser treatment measured at the end of the study 3. Follow up rates: the proportion of patients who return for follow up at 12 months 4. Patient-reported outcome measures (POEM) measured using a standard POEM questionnaire at 1 week after the first treatment

—

Countries

Nigeria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026