Panretinal PhotocoagulationNCT07157553
Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density .
An observational study of Panretinal Photocoagulation, run by Assiut University.
Trial summary
This study investigates the effect of argon laser panretinal photocoagulation (PRP) on the corneal endothelial cell density (ECD) in patients with proliferative diabetic retinopathy (PDR) by comparing ECD measurements before and after PRP treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Panretinal Photocoagulation
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of 45 newly diagnosed patients of any age or sex with proliferative diabetic retinopathy who require panretinal photocoagulation. The inclusion criteria cover patients irrespective of age or sex who are newly diagnosed with proliferative diabetic retinopathy and are indicated for argon laser panretinal photocoagulation. Exclusion criteria include any history of corneal disease, previous intraocular surgeries, glaucoma, or intraocular inflammation to reduce confounding factors affecting corneal endothelial measurements. This helps to ensure that changes detected in corneal endothelial cell density and morphology are primarily attributable to the laser intervention rather than underlying ocular comorbidities
Who may be able to join
- Patients from either sex with any age newly diagnosed PDR requring PRP .
Who cannot join
- history of corneal disease
- previous intraocular surgery
- glaucoma or intraocuar inflamation .
About this study
Official title: Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density Among Patients With Proliferative Diabetic Retinopathy .
This study investigates the effect of argon laser panretinal photocoagulation (PRP) on the corneal endothelial cell density (ECD) in patients with proliferative diabetic retinopathy (PDR) by comparing ECD measurements before and after PRP treatment.
Read the detailed description
Proliferative diabetic retinopathy (PDR) is characterized by abnormal neovascularization driven by ischemic retinal tissue hypoxia and elevated vascular endothelial growth factor (VEGF) levels. Argon laser retinal photocoagulation (ALRP) is a standard treatment that applies thermal damage to the retinal pigment epithelium, reducing retinal oxygen demand and VEGF production, thereby causing regression of neovascular vessels. However, the laser light must pass through the anterior eye structures, potentially causing thermal and inflammatory damage to tissues such as the corneal endothelium, which is crucial for maintaining corneal transparency. This prospective observational clinical study conducted at Assuit University Hospital evaluates the impact of ALRP on corneal endothelial cell density using specular microscopy before, 1 week, and 1 month after PRP treatment in newly diagnosed PDR patients. Secondary outcomes include changes in cell morphology such as hexagonality and coefficient of variation, indicative of endothelial cell health and stability.
- Conditions
- Panretinal Photocoagulation
- Keywords
- panretinal photocoagulation, corneal endothelial cell density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The study population consists of 45 newly diagnosed patients of any age or sex with proliferative di | The inclusion criteria cover patients irrespective of age or sex who are newly diagnosed with proliferative diabetic retinopathy and are indicated for argon laser panretinal photocoagulation. Exclusion criteria include any history of corneal disease, previous intraocular surgeries, glaucoma, or intraocular inflammation to reduce confounding factors affecting corneal endothelial measurements. This helps to ensure that changes detected in corneal endothelial cell density and morphology are primarily attributable to the laser intervention rather than underlying ocular comorbidities. The sample size calculation determined that 45 patients would provide sufficient power to detect statistically significant changes, analyzed using paired t-tests and ANOVA for repeated measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corneal Endothelial Cell Density (ECD) after PRP
The primary outcome is the quantitative change in the corneal endothelial cell density measured by specular microscopy, comparing pre-treatment baseline values with post-treatment values at 1 week and 1 month intervals. This measure reflects the potential impact of ALRP on the corneal endothelial integrity, crucial for corneal transparency and function.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panretinal PhotocoagulationStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahlam Abdelhady Mohamad Omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157553
- Sponsor's protocol ID
- argon laser photocoagulation
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203.
PubMed 7526212
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density Among Patients With Proliferative Diabetic Retinopathy .
- ClinicalTrials.gov ID
- NCT07157553
- Acronym / sponsor ID
- argon laser photocoagulation
- Conditions
- Panretinal Photocoagulation
- Keywords
- panretinal photocoagulation, corneal endothelial cell density
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Sep 2025 (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.
This study investigates the effect of argon laser panretinal photocoagulation (PRP) on the corneal endothelial cell density (ECD) in patients with proliferative diabetic retinopathy (PDR) by comparing ECD measurements before and after PRP treatment.
Detailed description
Proliferative diabetic retinopathy (PDR) is characterized by abnormal neovascularization driven by ischemic retinal tissue hypoxia and elevated vascular endothelial growth factor (VEGF) levels. Argon laser retinal photocoagulation (ALRP) is a standard treatment that applies thermal damage to the retinal pigment epithelium, reducing retinal oxygen demand and VEGF production, thereby causing regression of neovascular vessels. However, the laser light must pass through the anterior eye structures, potentially causing thermal and inflammatory damage to tissues such as the corneal endothelium, which is crucial for maintaining corneal transparency. This prospective observational clinical study conducted at Assuit University Hospital evaluates the impact of ALRP on corneal endothelial cell density using specular microscopy before, 1 week, and 1 month after PRP treatment in newly diagnosed PDR patients. Secondary outcomes include changes in cell morphology such as hexagonality and coefficient of variation, indicative of endothelial cell health and stability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population consists of 45 newly diagnosed patients of any age or sex with proliferative di | – | –The inclusion criteria cover patients irrespective of age or sex who are newly diagnosed with proliferative diabetic retinopathy and are indicated for argon laser panretinal photocoagulation. Exclusion criteria include any history of corneal disease, previous intraocular surgeries, glaucoma, or intraocular inflammation to reduce confounding factors affecting corneal endothelial measurements. This helps to ensure that changes detected in corneal endothelial cell density and morphology are primarily attributable to the laser intervention rather than underlying ocular comorbidities. The sample size calculation determined that 45 patients would provide sufficient power to detect statistically significant changes, analyzed using paired t-tests and ANOVA for repeated measures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of 45 newly diagnosed patients of any age or sex with proliferative diabetic retinopathy who require panretinal photocoagulation. The inclusion criteria cover patients irrespective of age or sex who are newly diagnosed with proliferative diabetic retinopathy and are indicated for argon laser panretinal photocoagulation. Exclusion criteria include any history of corneal disease, previous intraocular surgeries, glaucoma, or intraocular inflammation to reduce confounding factors affecting corneal endothelial measurements. This helps to ensure that changes detected in corneal endothelial cell density and morphology are primarily attributable to the laser intervention rather than underlying ocular comorbidities
Key inclusion criteria (1 listed)
- Patients from either sex with any age newly diagnosed PDR requring PRP .
Key exclusion criteria (3 listed)
- history of corneal disease
- previous intraocular surgery
- glaucoma or intraocuar inflamation .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Corneal Endothelial Cell Density (ECD) after PRP
Time frame: baseline
The primary outcome is the quantitative change in the corneal endothelial cell density measured by specular microscopy, comparing pre-treatment baseline values with post-treatment values at 1 week and 1 month intervals. This measure reflects the potential impact of ALRP on the corneal endothelial integrity, crucial for corneal transparency and function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 7526212Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Panretinal Photocoagulation, run by Assiut University.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Corneal Endothelial Cell Density (ECD) after PRP (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157553, which also lists 1 linked publication.
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 5 Sep 2025.