- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543564
Prophylactic PRP in Moderate NPDR
September 14, 2022 updated by: Khaled Abdelazeem, Assiut University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71515
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with moderate NPDR at high risk
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BCVA
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
September 14, 2022
First Submitted That Met QC Criteria
September 14, 2022
First Posted (Actual)
September 16, 2022
Study Record Updates
Last Update Posted (Actual)
September 16, 2022
Last Update Submitted That Met QC Criteria
September 14, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17300819
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eye Diseases
-
University of Alabama at BirminghamPfizerCompletedVision | Eye Disease | Eye CareUnited States
-
TBF Genie TissulaireCompletedEnucleated; Eye | Eye CancerFrance
-
Kao (Taiwan) CorporationChang Gung Memorial HospitalCompletedEye Fatigue | Dry Eye SymptomTaiwan
-
National Eye Institute (NEI)RecruitingInherited Eye DiseaseUnited States, United Kingdom, China, Pakistan, Philippines, Ukraine, India, Italy
-
National Eye Institute (NEI)Recruiting
-
National Eye Institute (NEI)RecruitingGenetic Eye DiseaseUnited States
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
OptovueCompletedNo Eye DiseaseUnited States, United Kingdom
-
National Eye Institute (NEI)CompletedHereditary Eye DiseaseUnited States
Clinical Trials on PRP
-
Sun Yat-sen UniversityUnknownSevere Non-proliferative Diabetic RetinopathyChina
-
Ankara Universitesi TeknokentCompleted
-
National Defense Medical Center, TaiwanTri-Service General HospitalRecruitingAnkle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeTaiwan
-
Postgraduate Institute of Dental Sciences RohtakUnknownPeriapical Lesions
-
Cairo UniversityRecruiting
-
University of Colorado, DenverTerumo BCTCompletedOsteochondritis DissecansUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingDry Age-related Macular DegenerationItaly
-
Yantai Yuhuangding HospitalRecruitingKnee OsteoarthritisChina
-
Yantai Yuhuangding HospitalTerminated
-
Anita Syla LokajEnrolling by invitation