Clinical trial NCT05547789: Assessment Of Diabetic Maculopathy Changes After Phacoemulsification by Using Optical Coherence Tomography
Official title: Assessment Of Diabetic Maculopathy Changes After Phacoemulsification by Using Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maculopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 .

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Macular changes in diabetic patients after phacoemulsification
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University
city: Assiut
country: Egypt
facility: Egypt
Study officials:
affiliation: Assiut University
name: Mohamed T. Abd Elmonaiem, Prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Gamal El Dein R. Osman, Ass prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Momen M. Aly, Lecture
role: STUDY_DIRECTOR
References:
citation: 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.