Assessment Of Diabetic Maculopathy Changes After Phacoemulsification by Using Optical Coherence Tomography

NCT ID: NCT05547789

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-04-30

Brief Summary

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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

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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

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Maculopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

non steroidal anti inflammatory drugs

Intervention Type DRUG

effect of non steroidal anti inflammatory drugs on macular changes

Control group

No interventions assigned to this group

Interventions

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non steroidal anti inflammatory drugs

effect of non steroidal anti inflammatory drugs on macular changes

Intervention Type DRUG

Other Intervention Names

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optical coherence tomography

Eligibility Criteria

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Inclusion Criteria

Controlled type 2 non proliferative diabetic retinopathy (NPDR) patients. Immature cataract which does not interfere with ocular imaging.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nermeen Mohammed Ali Hashim

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed T. Abd Elmonaiem, Prof

Role: STUDY_DIRECTOR

Assiut University

Gamal El Dein R. Osman, Ass prof

Role: STUDY_DIRECTOR

Assiut University

Momen M. Aly, Lecture

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assuit University

Asyut, , Egypt

Site Status

Egypt

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Nermeen M. Ali, Master

Role: CONTACT

01015910306

References

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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.

Reference Type BACKGROUND
PMID: 32897932 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/32897932/

DIABETIC MACULAR EDEMA AND CATARACT SURGERY: Phacoemulsification Combined With Dexamethasone Intravitreal Implant Compared With Standard Phacoemulsification

Other Identifiers

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Macular changes after phaco

Identifier Type: -

Identifier Source: org_study_id

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