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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05547789
Collaborator
(none)
30
2
17
15
0.9

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Drug: non steroidal anti inflammatory drugs

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment Of Diabetic Maculopathy Changes After Phacoemulsification by Using Optical Coherence Tomography
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Study group

Drug: non steroidal anti inflammatory drugs
effect of non steroidal anti inflammatory drugs on macular changes
Other Names:
  • optical coherence tomography
  • Control group

    Outcome Measures

    Primary Outcome Measures

    1. Macular changes in diabetic patients after phacoemulsification [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 .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assuit University Assiut Egypt
    2 Egypt Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Mohamed T. Abd Elmonaiem, Prof, Assiut University
    • Study Director: Gamal El Dein R. Osman, Ass prof, Assiut University
    • Study Director: Momen M. Aly, Lecture, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Nermeen Mohammed Ali Hashim, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05547789
    Other Study ID Numbers:
    • Macular changes after phaco
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2022