Eye DiseasesNCT05543564
Prophylactic PRP in Moderate NPDR
An observational study of Eye Diseases and Diabetes, run by Assiut University at 1 site in Egypt.
Trial summary
Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to severe visual impairment and 1.07% of… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Eye Diseases, Diabetes, Diabetic Retinopathy
- What is being tested?
- PRP
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate NPDR at high risk
Who may be able to join
- Patients with moderate NPDR at high risk which includ:
- Patients with PDR in the other eye
- Patients whose Glycosylated Haemoglobin (HbA1c) more than 8 %.
- Patients with early cataract
- Patients on regular renal dialysis or with impaired renal function
- Patients with restricted mobility because of neurological or orthopedic conditions
- Patients dependent on others, including old age.
- Women in rural areas, who are dependent on the accompaniment of a male relative.
Who cannot join
- Any patient who or whose relatives confirmed their attendance for regular follow-up according to the planned schedules after being informed of the possible complications which could happen if he or she did not attend.
- Patients with clinically significant macular edema (CSME).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Case for Selective Prophylactic Pan-retinal Photocoagulation in Moderate Non-Proliferative Diabetic Retinopathy in Ophthalmic Practice in Low- Resource Settings
Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to severe visual impairment and 1.07% of blindness. Pan retinal photocoagulation (PRP) remains the gold standard treatment for preventing visual loss in PDR. Scatter photocoagulation is not recommended for eyes with mild or moderate non-proliferative diabetic retinopathy (NPDR) provided careful follow-up can be maintained,. When retinopathy is more severe, scatter photocoagulation should be considered and should not be delayed if the eye has reached the high-risk proliferative stage. As many as 27% of patients with moderate NPDR are estimated to progress to PDR in 1 year; therefore, they should be seen every 4 to 8 months. This ideal, good as it is, is not what ophthalmic practice has to deal with in communities of low-resource settings, where patients often seek medical advice due to visual complaints from the complications of PDR without being diagnosed in the non-proliferative stage or high risk PDR. Screening protocols are not followed, a situation aggravated during the COVID pandemic lockdown.
- Conditions
- Eye Diseases, Diabetes, Diabetic Retinopathy
- Being tested
- PRP
- Medical subject headings
- Eye Diseases, Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPProcedure or surgery
Single session prophylactic early Pan-retinal Photocoagulation
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Feb 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543564
- Sponsor's protocol ID
- 17300819
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Case for Selective Prophylactic Pan-retinal Photocoagulation in Moderate Non-Proliferative Diabetic Retinopathy in Ophthalmic Practice in Low- Resource Settings
- ClinicalTrials.gov ID
- NCT05543564
- Acronym / sponsor ID
- 17300819
- Conditions
- Eye Diseases, Diabetes, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to severe visual impairment and 1.07% of blindness. Pan retinal photocoagulation (PRP) remains the gold standard treatment for preventing visual loss in PDR. Scatter photocoagulation is not recommended for eyes with mild or moderate non-proliferative diabetic retinopathy (NPDR) provided careful follow-up can be maintained,. When retinopathy is more severe, scatter photocoagulation should be considered and should not be delayed if the eye has reached the high-risk proliferative stage. As many as 27% of patients with moderate NPDR are estimated to progress to PDR in 1 year; therefore, they should be seen every 4 to 8 months. This ideal, good as it is, is not what ophthalmic practice has to deal with in communities of low-resource settings, where patients often seek medical advice due to visual complaints from the complications of PDR without being diagnosed in the non-proliferative stage or high risk PDR. Screening protocols are not followed, a situation aggravated during the COVID pandemic lockdown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate NPDR at high risk
Key inclusion criteria (8 listed)
- Patients with PDR in the other eye
- Patients whose Glycosylated Haemoglobin (HbA1c) more than 8 %.
- Patients with early cataract
- Patients on regular renal dialysis or with impaired renal function
- Patients with restricted mobility because of neurological or orthopedic conditions
Key exclusion criteria (2 listed)
- Any patient who or whose relatives confirmed their attendance for regular follow-up according to the planned schedules after being informed of the possible complications which could happen if he or she did not attend.
- Patients with clinically significant macular edema (CSME).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRPSingle session prophylactic early Pan-retinal Photocoagulation | Procedure or surgery | – |
Primary outcome
BCVA
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
Related trials for Eye Diseases
Active, not recruitingPhase 2
Safety and Efficacy of the PAINLESS Nerve Growth Factor CHF6467 in Optic Pathway Glioma (OPG)
Optic Pathway Glioma
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases and Diabetes, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.