MaculopathyMaculopathyNCT05547789
Assessment Of Diabetic Maculopathy Changes After Phacoemulsification by Using Optical Coherence Tomography
An observational study of Maculopathy, run by Assiut University at 2 sites in Egypt.
Trial summary
Investigators aimed to assess the macular changes with OCT after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (NPDR) at the time of surgery and the effect of perioperative and postoperative topical NSAIDS on macular changes . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maculopathy
- What is being tested?
- non steroidal anti inflammatory drugs
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- Mar 2023to Apr 2024
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: preoperatively ,Nonsteroidal anti inflammatory drugs was used for prophylaxis before surgery at the postoperative week 1 we gave the same medication to this group
Who may be able to join
- Controlled type 2 non proliferative diabetic retinopathy (NPDR) patients. Immature cataract which does not interfere with ocular imaging.
Who cannot join
- Patient with dense cataract or vitreous hemorrhage interfering with measurement of central macular thickness Chronic uveitis Any posterior segment pathology that could affect retinal thickness Patient with complicated cataract surgery.
Trial locations and contacts
2 sites in 1 country.
About this study
Investigators aimed to assess the macular changes with OCT after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (NPDR) at the time of surgery and the effect of perioperative and postoperative topical NSAIDS on macular changes .
Read the detailed description
Diabetic patients pose a particular challenge because of the tendency for early formation of cataract in them and propensity to develop macular edema after cataract surgery. Macular edema (ME) is a major cause of vision loss after cataract surgery in patients with diabetes .
Macular edema is a common cause of unfavorable visual outcome after cataract surgery. Clinically significant cystoid macular edema (CSME) has a reported incidence of 1% to 2% after cataract surgery. Diabetes has been associated with an increased incidence of postoperative macular edema. The incidence of macular edema on optical coherence tomography (OCT) was 22% in diabetic eyes undergoing cataract surgery. The macular edema after cataract surgery in diabetic patients could be caused by the cataract surgery or diabetes itself, but it might be hard to differentiate between these two causes .
The level of the preexisting diabetic retinopathy (DR), the presence of clinically significant macular edema (CSME) before the surgery, and duration and regulation of diabetes are all important indicators of postoperative CME . Optical coherence tomography (OCT) has been established as a practical method for examining retinal architecture. OCT, with its noninvasive nature, has been proven to be an indispensable tool for diagnosing retinal pathologies, including cystoid macular edema (CME). Many studies have reported incidences of CME and macular thickness changes, determined by OCT following uneventful cataract surgeries .Nonsteroidal anti-inflammatory drugs (NSAIDS) are widely used and studied by cataract surgeons for varied benefits in the perioperative and postoperative period. Nonsteroidal anti-inflammatory drugs (NSAIDs), a class of medications that inhibit cyclooxygenase (COX) enzymes from producing pro-inflammatory prostaglandins, have multiple indications in the perioperative period including pain control, reducing inflammation, improving intraocular mydriasis, and preventing postoperative cystoid macular edema (CME) .Cataract surgeons often use NSAIDs postoperatively to control patient pain, inflammation, and prevent CME, the most prevalent complication affecting postoperative visual recovery .
- Conditions
- Maculopathy
- Being tested
- non steroidal anti inflammatory drugs
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non steroidal anti inflammatory drugsDrug
Also called optical coherence tomography
effect of non steroidal anti inflammatory drugs on macular changes
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described Receives: Drug: non steroidal anti inflammatory drugs | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular changes in diabetic patients after phacoemulsification
Invgatorsiest aimed to examine the macular changes with OCT after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (NPDR) at the time of surgery and the effect of perioperative and postoperative topical NSAIDS on macular changes .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (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 MaculopathyStudies 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
- 30 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Mohammed Ali Hashim, Assiut University
- Investigators
- Mohamed T. Abd Elmonaiem, Prof, Study director, Assiut UniversityGamal El Dein R. Osman, Ass prof, Study director, Assiut UniversityMomen M. Aly, Lecture, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547789
- Sponsor's protocol ID
- Macular changes after phaco
- Acronym
- Maculopathy
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Furino C, Boscia F, Niro A, D'Addario M, Grassi MO, Saglimbene V, Reibaldi M, Alessio G. DIABETIC MACULAR EDEMA AND CATARACT SURGERY: Phacoemulsification Combined With Dexamethasone Intravitreal Implant Compared With Standard Phacoemulsification. Retina. 2021 May 1;41(5):1102-1109. doi: 10.1097/IAE.0000000000002974.
PubMed 32897932
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Diabetic Maculopathy Changes After Phacoemulsification by Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05547789
- Acronym / sponsor ID
- Maculopathy / Macular changes after phaco
- Conditions
- Maculopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 21 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.
Investigators aimed to assess the macular changes with OCT after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (NPDR) at the time of surgery and the effect of perioperative and postoperative topical NSAIDS on macular changes .
Detailed description
Diabetic patients pose a particular challenge because of the tendency for early formation of cataract in them and propensity to develop macular edema after cataract surgery. Macular edema (ME) is a major cause of vision loss after cataract surgery in patients with diabetes .
Macular edema is a common cause of unfavorable visual outcome after cataract surgery. Clinically significant cystoid macular edema (CSME) has a reported incidence of 1% to 2% after cataract surgery. Diabetes has been associated with an increased incidence of postoperative macular edema. The incidence of macular edema on optical coherence tomography (OCT) was 22% in diabetic eyes undergoing cataract surgery. The macular edema after cataract surgery in diabetic patients could be caused by the cataract surgery or diabetes itself, but it might be hard to differentiate between these two causes .
The level of the preexisting diabetic retinopathy (DR), the presence of clinically significant macular edema (CSME) before the surgery, and duration and regulation of diabetes are all important indicators of postoperative CME . Optical coherence tomography (OCT) has been established as a practical method for examining retinal architecture. OCT, with its noninvasive nature, has been proven to be an indispensable tool for diagnosing retinal pathologies, including cystoid macular edema (CME). Many studies have reported incidences of CME and macular thickness changes, determined by OCT following uneventful cataract surgeries .Nonsteroidal anti-inflammatory drugs (NSAIDS) are widely used and studied by cataract surgeons for varied benefits in the perioperative and postoperative period. Nonsteroidal anti-inflammatory drugs (NSAIDs), a class of medications that inhibit cyclooxygenase (COX) enzymes from producing pro-inflammatory prostaglandins, have multiple indications in the perioperative period including pain control, reducing inflammation, improving intraocular mydriasis, and preventing postoperative cystoid macular edema (CME) .Cataract surgeons often use NSAIDs postoperatively to control patient pain, inflammation, and prevent CME, the most prevalent complication affecting postoperative visual recovery .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: non steroidal anti inflammatory drugs |
| Control group | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- preoperatively ,Nonsteroidal anti inflammatory drugs was used for prophylaxis before surgery at the postoperative week 1 we gave the same medication to this group
Key inclusion criteria (1 listed)
- Controlled type 2 non proliferative diabetic retinopathy (NPDR) patients. Immature cataract which does not interfere with ocular imaging.
Key exclusion criteria (1 listed)
- Patient with dense cataract or vitreous hemorrhage interfering with measurement of central macular thickness Chronic uveitis Any posterior segment pathology that could affect retinal thickness Patient with complicated cataract surgery.
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 |
|---|---|---|
| non steroidal anti inflammatory drugsAlso: optical coherence tomographyeffect of non steroidal anti inflammatory drugs on macular changes | Drug | Study group |
Primary outcome
Macular changes in diabetic patients after phacoemulsification
Time frame: baseline
Invgatorsiest aimed to examine the macular changes with OCT after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (NPDR) at the time of surgery and the effect of perioperative and postoperative topical NSAIDS on macular changes .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 32897932Furino C, Boscia F, Niro A, D'Addario M, Grassi MO, Saglimbene V, Reibaldi M, Alessio G. DIABETIC MACULAR EDEMA AND CATARACT SURGERY: Phacoemulsification Combined With Dexamethasone Intravitreal Implant Compared With Standard Phacoemulsification. Retina. 2021 May 1;41(5):1102-1109. doi: 10.1097/IAE.0000000000002974.
- DIABETIC MACULAR EDEMA AND CATARACT SURGERY: Phacoemulsification Combined With Dexamethasone Intravitreal Implant Compared With Standard PhacoemulsificationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mohamed T. Abd Elmonaiem, Prof study director
Assiut University
Gamal El Dein R. Osman, Ass prof study director
Assiut University
Momen M. Aly, Lecture study director
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maculopathy, run by Assiut University at 2 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen M. Ali, Master (01015910306, nirmin93147@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular changes in diabetic patients after phacoemulsification (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 NCT05547789, 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 10 Jan 2023.