Evidence map›Paper›PMID 36401233›Full record

Trial reportBMC ophthalmology2022

Combined phacoemulsification surgery and intravitreal triamcinolone injection versus stand-alone surgery in patients with type 2 diabetes: a prospective randomized trial.

Sarah Zaher Addeen, Iyad Shaddoud

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05413330 (Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05413330 phase2 / phase3completednot on this map

Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial

TypeinterventionalSponsorDamascus UniversityRan2020 to 2022Enrolled73ConditionsDiabete Type 2, Cataract, Triamcinolone Acetonide, Intravitreal InjectionArmsTriamcinolone Acetonide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Sarah Zaher AddeenDepartment of ophthalmology, Al Mouassat University Hospital, Damascus University, Damascus, Syria. sarah.zaheraddeen@gmail.com.ORCID https://orcid.org/0000-0003-3680-7351
Iyad ShaddoudDepartment of ophthalmology, Al Mouassat University Hospital, Damascus University, Damascus, Syria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe would assess the efficacy of intravitreal injection of triamcinolone acetonide IVTA combined with standard phacoemulsification on the central subfield macular thickness (CSMT), the progression of diabetic retinopathy (DR), and the corrected distant visual acuity (CDVA) in type 2 diabetic patients.

methodsIn this prospective single-blinded randomized clinical trial we recruited patients with type 2 diabetes who were eligible for cataract surgery. The patients were randomly assigned to two groups. The case group received an intravitreal IVTA at the end of phacoemulsification, and the control group had routine surgery. CSMT, progression of DR, CDVA, IOP, and adverse events including endophthalmitis were compared between the groups preoperatively and at 1, 3, and 6 months postoperatively.

resultsAmong a total of 66 patients that were treated within the study period, 50 patients were included in the final analysis. The case group comprised 21 eyes, and the control group included 29 eyes. Regression models and corrected ANOVA test for repeated measures showed a significant reduction in CSMT at 3 and 6 months postoperatively, which was most significant when the preoperative CSMT was ≥300 μm, with a cut-off value of 347.3 μm in the case group (p < 0.000). DR progression was halted in the case group at 6 months with 52.38% of patients having their DR classified as moderate (P = 0.012). CDVA was significantly improved from baseline 6/60 (logMAR 1.0) pre-op to 6/6 (logMAR 0.00) at 6 months post-op in the case group, and from baseline 6/120 (logMAR 1.3) pre-op to 6/12 (logMAR 0.3) at 6 months post-op in the control group. The gain in visual acuity was significantly higher in the case group at all study points (p < 0.001). No significant rise in IOP was observed at any study point in both groups (p = 0.23 > 0.05). No endophthalmitis was recorded.

conclusionsDiabetic patients benefit significantly from cataract surgery. This study supports IVTA injection at the end of phacoemulsification in diabetic patients. Triamcinolone is an affordable (which is of particular importance in low-income countries as per our setting), and relatively safe "phaco-enhancer".

trial registrationNCT05413330. Initial release 10/06/2022. Unique Protocol ID: UDMS-Opthal-01-2022.

Indexed as

CataractDiabetes Mellitus, Type 2Diabetic RetinopathyMacular EdemaPhacoemulsificationGlucocorticoidsHumansIntravitreal InjectionsProspective StudiesTomography, Optical CoherenceTriamcinolone AcetonideGlucocorticoidsTriamcinolone AcetonideCDVACentral subfield macular thicknessCSMTDiabetesDiabetic retinopathyDistance corrected visual acuityDRIntravitrealIOPIVTAPhacoemulsificationTriamcinolone acetonide

Identifiers

PMID36401233
PMCPMC9675215

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.